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Antiplaque/Antigingivitis Effect of Lacer Oros Integral (LacerINT)

Primary Purpose

Periodontitis, Dental Plaque, Gingival Inflammation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).
control group
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

35 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 35-64 years old.
  • Periodontitis patients, already enrolled in a SPT, for at least 6 months, and the last SPT visit in the previous 6 months.
  • Systemically healthy, following the criteria of the American Society of Anesthesiologists (ASA), for patients ASA type I or II (see also exclusion criteria).
  • Presence of at least three evaluable teeth in each quadrant.
  • Moderate gingival inflammation (≥40% bleeding on marginal probing, BOMP) (Van der Weijden, Timmerman, Nijboer, Reijerse, & Van der Velden, 1994) and Turesky plaque index ≥1.5. Also 2017 World Workshop criteria and bleeding on probing (BOP) (Ainamo & Bay, 1975) criteria will be considered. The primary criteria will be BOP ≥30% and Turesky plaque index ≥1.5
  • No orthodontic banding or removable prosthesis.
  • Subjects willing to participate and comply with the requirements of the study.
  • Complains of dentin hypersensitivity in, at least, one evaluable tooth. Dentin hypersensitivity will be confirmed with evaporative sensitivity (Schiff et al., 1994), with a minimum score of 2-3 (West et al., 2013), although a score of 1 will also be considered as adequate. In order to be eligible, the selected tooth must not have a current desensitizing therapy, must not have been restored in the last 3 moths, or have a crown or a big restoration. Only incisors, canines and premolars will be considered (Holland, Narhi, Addy, Gangarosa, & Orchardson, 1997).

Exclusion Criteria:

  • Untreated or uncontrolled periodontitis
  • Regular use of antiseptic-containing and/or anti-hypersensitivity mouth rinses.
  • Antibiotic intake within the previous month.
  • Excessive exposure to acids (eating disorders, chronic regurgitation).
  • Chronic use of analgesic or anti-inflammatory drugs.
  • Pregnant women.
  • Any adverse medical history (diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions.
  • Conditions which requires antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).

Sites / Locations

  • Faculty of Dentistry, Univesity Complutense, Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Control Group

Arm Description

The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).

The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain).

Outcomes

Primary Outcome Measures

Change in BOP (Baseline-12 weeks)
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.

Secondary Outcome Measures

Change in BOP (Baseline-6 weeks)
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Change in BOP (6-12 weeks)
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
BOP_baseline
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
BOP_6 weeks
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
BOP_12 weeks
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
BOMP_baseline
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
BOMP_6 weeks
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
BOMP_12 weeks
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
Change in BOMP (Baseline-12 weeks)
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
Change in BOMP (Baseline-6 weeks)
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
Change in BOMP (6-12 weeks)
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
Change in Dental Plaque (Baseline-12 weeks)
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Change in Dental Plaque (Baseline-6 weeks)
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Change in Dental Plaque (6-12 weeks)
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Dental Plaque_Baseline
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Dental Plaque_6 weeks
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Dental Plaque_12 weeks
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Staining of teeth_baseline
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Gründemann, Timmerman, IJzerman, Van der Weijden, & Van der Weijden, 2000), recorded at nine areas per tooth (three mesial, three medial, three distal) (Koertge, Gunsolley, Domke, & Nelson, 1993). Stain will be graded using the intensity stain index of Lobene (Lobene, 1968). Presence of staining will be assessed in the upper and lower anterior buccal sites, by evaluating standardized clinical photographs by two calibrated examiners.
Staining of teeth_6 weeks
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Gründemann, Timmerman, IJzerman, Van der Weijden, & Van der Weijden, 2000), recorded at nine areas per tooth (three mesial, three medial, three distal) (Koertge, Gunsolley, Domke, & Nelson, 1993). Stain will be graded using the intensity stain index of Lobene (Lobene, 1968). Presence of staining will be assessed in the upper and lower anterior buccal sites, by evaluating standardized clinical photographs by two calibrated examiners.
Staining of teeth_12 weeks
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Gründemann, Timmerman, IJzerman, Van der Weijden, & Van der Weijden, 2000), recorded at nine areas per tooth (three mesial, three medial, three distal) (Koertge, Gunsolley, Domke, & Nelson, 1993). Stain will be graded using the intensity stain index of Lobene (Lobene, 1968). Presence of staining will be assessed in the upper and lower anterior buccal sites, by evaluating standardized clinical photographs by two calibrated examiners.
Probing pocket depth_baseline
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Probing pocket depth_6 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Probing pocket depth_12 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Recession_baseline
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Recession_6 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Recession_12 weeks
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Dentin hypersensitivity_baseline
Dentin hypersensitivity will be explored by means of evaporative stimulus, with two distinct assessments: an objective assessment, using the Schiff scale (Schiff et al., 1994): a subjective assessment, using the Visual Analogue Scales (VAS), as reported by the patient. Dentin hypersensitivity will be scored in just one tooth, identified according to selection criteria, listed in the inclusion criteria. The same tooth will be also scored in the follow up visits. If the patient identifies more than one tooth with dentin hypersensitivity at baseline, the one with a higher level of pain (according to the patient evaluation), will be selected. The clinician will take the final decision concerning the selected tooth.
Dentin hypersensitivity_6 weeks
Dentin hypersensitivity will be explored by means of evaporative stimulus, with two distinct assessments: an objective assessment, using the Schiff scale (Schiff et al., 1994): a subjective assessment, using the Visual Analogue Scales (VAS), as reported by the patient. Dentin hypersensitivity will be scored in just one tooth, identified according to selection criteria, listed in the inclusion criteria. The same tooth will be also scored in the follow up visits. If the patient identifies more than one tooth with dentin hypersensitivity at baseline, the one with a higher level of pain (according to the patient evaluation), will be selected. The clinician will take the final decision concerning the selected tooth.
Dentin hypersensitivity_12 weeks
Dentin hypersensitivity will be explored by means of evaporative stimulus, with two distinct assessments: an objective assessment, using the Schiff scale (Schiff et al., 1994): a subjective assessment, using the Visual Analogue Scales (VAS), as reported by the patient. Dentin hypersensitivity will be scored in just one tooth, identified according to selection criteria, listed in the inclusion criteria. The same tooth will be also scored in the follow up visits. If the patient identifies more than one tooth with dentin hypersensitivity at baseline, the one with a higher level of pain (according to the patient evaluation), will be selected. The clinician will take the final decision concerning the selected tooth.
Patient reported outcomes-1_6 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 1: Mouth rinse flavor (1: very bad; 10: very good).
Patient reported outcomes-1_12 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 1: Mouth rinse flavor (1: very bad; 10: very good).
Patient reported outcomes-2_6 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 2: How much time does the mouth rinse flavor lasts in your mouth (1: very low; 10: too much)
Patient reported outcomes-2_12 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 2: How much time does the mouth rinse flavor lasts in your mouth (1: very low; 10: too much)
Patient reported outcomes-3_6 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 3: Which is your perception of the food and drinks flavor when using the mouth rinse (1: much worse, 10: better).
Patient reported outcomes-3_12 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 3: Which is your perception of the food and drinks flavor when using the mouth rinse (1: much worse, 10: better).
Patient reported outcomes-4_6 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 4: Do you notice the teeth and the mucosa more sensitive after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Patient reported outcomes-4_12 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 4: Do you notice the teeth and the mucosa more sensitive after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Patient reported outcomes-5_6 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 5: Do you notice a drier mouth after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Patient reported outcomes-5_12 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 5: Do you notice a drier mouth after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Patient reported outcomes-6_6 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 6: Do you notice burning feeling after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Patient reported outcomes-6_12 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 6: Do you notice burning feeling after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Patient reported outcomes-7_6 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 7: Do you notice some staining on the teeth or tongue due to the use of the mouth rinse (1: no, absolutely; 10: yes, much more).
Patient reported outcomes-7_12 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 7: Do you notice some staining on the teeth or tongue due to the use of the mouth rinse (1: no, absolutely; 10: yes, much more).
Patient reported outcomes-8_6 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 8: Which is your general opinion after using the mouth rinse in this study (1: very bad; 10: very good).
Patient reported outcomes-8_12 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 8: Which is your general opinion after using the mouth rinse in this study (1: very bad; 10: very good).
Patient reported outcomes-9_6 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 9: Do you think that the mouth rinse use has improved your mouth health (1: no absolutely; 10: yes, much more).
Patient reported outcomes-9_12 weeks
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 9: Do you think that the mouth rinse use has improved your mouth health (1: no absolutely; 10: yes, much more).
Compliance_6 weeks
The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused mouth rinse bottles.
Compliance_12 weeks
The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused mouth rinse bottles.
Total counts (CFU/ml)_Baseline
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR
Total counts (CFU/ml)_6 weeks
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR
Total counts (CFU/ml)_12 weeks
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR
Proportion of periodontal pathogens (%)_Baseline
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Proportions of microbiota would be calculated as counts of the pathogen/total counts.
Proportion of periodontal pathogens (%)_6 weeks
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Proportions of microbiota would be calculated as counts of the pathogen/total counts.
Proportion of periodontal pathogens (%)_12 weeks
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Proportions of microbiota would be calculated as counts of the pathogen/total counts.
Prevalence of periodontal pathogens (%) in each group_baseline
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Prevalence would be defined as presence/absence of each pathogen.
Prevalence of periodontal pathogens (%) in each group_6 weeks
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Prevalence would be defined as presence/absence of each pathogen.
Prevalence of periodontal pathogens (%) in each group_12 weeks
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Prevalence would be defined as presence/absence of each pathogen.

Full Information

First Posted
April 26, 2021
Last Updated
July 24, 2023
Sponsor
Universidad Complutense de Madrid
Collaborators
Lacer, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04881357
Brief Title
Antiplaque/Antigingivitis Effect of Lacer Oros Integral
Acronym
LacerINT
Official Title
Evaluation of Antiplaque and Antigingivitis Effects of the New "Lacer Oros Acción Integral" Mouth Rinse Formulation.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 4, 2021 (Actual)
Primary Completion Date
July 10, 2022 (Actual)
Study Completion Date
July 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Lacer, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background; A new mouth rinse formulation ("Lacer Oros Acción Integral", Lacer SA, Barcelona, Spain) has been recently proposed, including O-Cymen-5-ol, potassium nitrate, zinc chloride, dipotassium glycyrrhizate, sodium fluoride, panthenol and xylitol, within its ingredients. Thus, it may be relevant to test the efficacy of this new "Lacer Oros Acción Integral" mouth rinse formulation in a RCT. Primary Objective: The primary objective of this RCT will be to evaluate the antiplaque/antigingivitis effects of the test mouth rinse. Population: Consecutive subjects in supportive periodontal therapy (SPT) will be screened at the Post-Graduate Periodontal Clinic in the University Complutense, Madrid, and enrolled in the clinical trial if they are periodontitis patients, already enrolled in a SPT, for at least 6 months, systemically healthy, with moderate gingival inflammation and complains of dentin hypersensitivity. Study design: pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial Intervention: The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain). The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain). Visits: Screening, baseline, 2 and 12 weeks. Outcomes: Periodontal clinical outcomes (plaque levels, gingival condition, probing pocket depth), Stainign, Microbiological outcomes (culture and qPCR). Patient reported outcomes, compliance, adverse effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Dental Plaque, Gingival Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain).
Intervention Type
Other
Intervention Name(s)
test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).
Intervention Description
The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain).
Primary Outcome Measure Information:
Title
Change in BOP (Baseline-12 weeks)
Description
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in BOP (Baseline-6 weeks)
Description
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time Frame
Change from baseline to 6 weeks
Title
Change in BOP (6-12 weeks)
Description
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time Frame
Change from 6 to 12 weeks
Title
BOP_baseline
Description
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time Frame
Baseline
Title
BOP_6 weeks
Description
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time Frame
6 weeks
Title
BOP_12 weeks
Description
Gingival Bleeding Index (Ainamo & Bay, 1975), by dichotomously assessing bleeding after gentle probing.
Time Frame
12 weeks
Title
BOMP_baseline
Description
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
Time Frame
Baseline
Title
BOMP_6 weeks
Description
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
Time Frame
6 weeks
Title
BOMP_12 weeks
Description
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
Time Frame
12 weeks
Title
Change in BOMP (Baseline-12 weeks)
Description
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
Time Frame
Change from baseline to 12 weeks
Title
Change in BOMP (Baseline-6 weeks)
Description
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
Time Frame
Change from baseline to 6 weeks
Title
Change in BOMP (6-12 weeks)
Description
The BOMP index by recording the presence or absence of bleeding within 30 seconds of probing on a scale 0-2 (Lie, Timmerman, Van der Velden, & Van der Weijden, 1998; Van der Weijden, Timmerman, Nijboer, et al., 1994).
Time Frame
Change from 6 to 12 weeks
Title
Change in Dental Plaque (Baseline-12 weeks)
Description
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Time Frame
Change from baseline to 12 weeks
Title
Change in Dental Plaque (Baseline-6 weeks)
Description
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Time Frame
Change from baseline to 6 weeks
Title
Change in Dental Plaque (6-12 weeks)
Description
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Time Frame
Change from 6 to 12 weeks
Title
Dental Plaque_Baseline
Description
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Time Frame
Baseline
Title
Dental Plaque_6 weeks
Description
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Time Frame
6 weeks
Title
Dental Plaque_12 weeks
Description
Dental plaque will be assessed using a disclosing solution (PlacControl®, Dentaid, Barcelona, Spain) with the Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962), scored at six sites per tooth.
Time Frame
12 weeks
Title
Staining of teeth_baseline
Description
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Gründemann, Timmerman, IJzerman, Van der Weijden, & Van der Weijden, 2000), recorded at nine areas per tooth (three mesial, three medial, three distal) (Koertge, Gunsolley, Domke, & Nelson, 1993). Stain will be graded using the intensity stain index of Lobene (Lobene, 1968). Presence of staining will be assessed in the upper and lower anterior buccal sites, by evaluating standardized clinical photographs by two calibrated examiners.
Time Frame
Baseline
Title
Staining of teeth_6 weeks
Description
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Gründemann, Timmerman, IJzerman, Van der Weijden, & Van der Weijden, 2000), recorded at nine areas per tooth (three mesial, three medial, three distal) (Koertge, Gunsolley, Domke, & Nelson, 1993). Stain will be graded using the intensity stain index of Lobene (Lobene, 1968). Presence of staining will be assessed in the upper and lower anterior buccal sites, by evaluating standardized clinical photographs by two calibrated examiners.
Time Frame
6 weeks
Title
Staining of teeth_12 weeks
Description
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Gründemann, Timmerman, IJzerman, Van der Weijden, & Van der Weijden, 2000), recorded at nine areas per tooth (three mesial, three medial, three distal) (Koertge, Gunsolley, Domke, & Nelson, 1993). Stain will be graded using the intensity stain index of Lobene (Lobene, 1968). Presence of staining will be assessed in the upper and lower anterior buccal sites, by evaluating standardized clinical photographs by two calibrated examiners.
Time Frame
12 weeks
Title
Probing pocket depth_baseline
Description
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time Frame
Baseline
Title
Probing pocket depth_6 weeks
Description
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time Frame
6 weeks
Title
Probing pocket depth_12 weeks
Description
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time Frame
12 weeks
Title
Recession_baseline
Description
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time Frame
Baseline
Title
Recession_6 weeks
Description
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time Frame
6 weeks
Title
Recession_12 weeks
Description
At six sites per tooth, with a millimetre periodontal probe (North Carolina)
Time Frame
12 weeks
Title
Dentin hypersensitivity_baseline
Description
Dentin hypersensitivity will be explored by means of evaporative stimulus, with two distinct assessments: an objective assessment, using the Schiff scale (Schiff et al., 1994): a subjective assessment, using the Visual Analogue Scales (VAS), as reported by the patient. Dentin hypersensitivity will be scored in just one tooth, identified according to selection criteria, listed in the inclusion criteria. The same tooth will be also scored in the follow up visits. If the patient identifies more than one tooth with dentin hypersensitivity at baseline, the one with a higher level of pain (according to the patient evaluation), will be selected. The clinician will take the final decision concerning the selected tooth.
Time Frame
Baseline
Title
Dentin hypersensitivity_6 weeks
Description
Dentin hypersensitivity will be explored by means of evaporative stimulus, with two distinct assessments: an objective assessment, using the Schiff scale (Schiff et al., 1994): a subjective assessment, using the Visual Analogue Scales (VAS), as reported by the patient. Dentin hypersensitivity will be scored in just one tooth, identified according to selection criteria, listed in the inclusion criteria. The same tooth will be also scored in the follow up visits. If the patient identifies more than one tooth with dentin hypersensitivity at baseline, the one with a higher level of pain (according to the patient evaluation), will be selected. The clinician will take the final decision concerning the selected tooth.
Time Frame
6 weeks
Title
Dentin hypersensitivity_12 weeks
Description
Dentin hypersensitivity will be explored by means of evaporative stimulus, with two distinct assessments: an objective assessment, using the Schiff scale (Schiff et al., 1994): a subjective assessment, using the Visual Analogue Scales (VAS), as reported by the patient. Dentin hypersensitivity will be scored in just one tooth, identified according to selection criteria, listed in the inclusion criteria. The same tooth will be also scored in the follow up visits. If the patient identifies more than one tooth with dentin hypersensitivity at baseline, the one with a higher level of pain (according to the patient evaluation), will be selected. The clinician will take the final decision concerning the selected tooth.
Time Frame
12 weeks
Title
Patient reported outcomes-1_6 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 1: Mouth rinse flavor (1: very bad; 10: very good).
Time Frame
6 weeks
Title
Patient reported outcomes-1_12 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 1: Mouth rinse flavor (1: very bad; 10: very good).
Time Frame
12 weeks
Title
Patient reported outcomes-2_6 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 2: How much time does the mouth rinse flavor lasts in your mouth (1: very low; 10: too much)
Time Frame
6 weeks
Title
Patient reported outcomes-2_12 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 2: How much time does the mouth rinse flavor lasts in your mouth (1: very low; 10: too much)
Time Frame
12 weeks
Title
Patient reported outcomes-3_6 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 3: Which is your perception of the food and drinks flavor when using the mouth rinse (1: much worse, 10: better).
Time Frame
6 weeks
Title
Patient reported outcomes-3_12 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 3: Which is your perception of the food and drinks flavor when using the mouth rinse (1: much worse, 10: better).
Time Frame
12 weeks
Title
Patient reported outcomes-4_6 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 4: Do you notice the teeth and the mucosa more sensitive after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Time Frame
6 weeks
Title
Patient reported outcomes-4_12 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 4: Do you notice the teeth and the mucosa more sensitive after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Time Frame
12 weeks
Title
Patient reported outcomes-5_6 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 5: Do you notice a drier mouth after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Time Frame
6 weeks
Title
Patient reported outcomes-5_12 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 5: Do you notice a drier mouth after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Time Frame
12 weeks
Title
Patient reported outcomes-6_6 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 6: Do you notice burning feeling after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Time Frame
6 weeks
Title
Patient reported outcomes-6_12 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 6: Do you notice burning feeling after using the mouth rinse (1: no, absolutely; 10: yes, much more).
Time Frame
12 weeks
Title
Patient reported outcomes-7_6 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 7: Do you notice some staining on the teeth or tongue due to the use of the mouth rinse (1: no, absolutely; 10: yes, much more).
Time Frame
6 weeks
Title
Patient reported outcomes-7_12 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 7: Do you notice some staining on the teeth or tongue due to the use of the mouth rinse (1: no, absolutely; 10: yes, much more).
Time Frame
12 weeks
Title
Patient reported outcomes-8_6 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 8: Which is your general opinion after using the mouth rinse in this study (1: very bad; 10: very good).
Time Frame
6weeks
Title
Patient reported outcomes-8_12 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 8: Which is your general opinion after using the mouth rinse in this study (1: very bad; 10: very good).
Time Frame
12 weeks
Title
Patient reported outcomes-9_6 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 9: Do you think that the mouth rinse use has improved your mouth health (1: no absolutely; 10: yes, much more).
Time Frame
6 weeks
Title
Patient reported outcomes-9_12 weeks
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, including nine different questions. Question 9: Do you think that the mouth rinse use has improved your mouth health (1: no absolutely; 10: yes, much more).
Time Frame
12 weeks
Title
Compliance_6 weeks
Description
The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused mouth rinse bottles.
Time Frame
12 weeks
Title
Compliance_12 weeks
Description
The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused mouth rinse bottles.
Time Frame
12 weeks
Title
Total counts (CFU/ml)_Baseline
Description
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR
Time Frame
Baseline
Title
Total counts (CFU/ml)_6 weeks
Description
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR
Time Frame
6 weeks
Title
Total counts (CFU/ml)_12 weeks
Description
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR
Time Frame
12 weeks
Title
Proportion of periodontal pathogens (%)_Baseline
Description
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Proportions of microbiota would be calculated as counts of the pathogen/total counts.
Time Frame
Baseline
Title
Proportion of periodontal pathogens (%)_6 weeks
Description
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Proportions of microbiota would be calculated as counts of the pathogen/total counts.
Time Frame
6 weeks
Title
Proportion of periodontal pathogens (%)_12 weeks
Description
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Proportions of microbiota would be calculated as counts of the pathogen/total counts.
Time Frame
12 weeks
Title
Prevalence of periodontal pathogens (%) in each group_baseline
Description
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Prevalence would be defined as presence/absence of each pathogen.
Time Frame
Baseline
Title
Prevalence of periodontal pathogens (%) in each group_6 weeks
Description
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Prevalence would be defined as presence/absence of each pathogen.
Time Frame
6 weeks
Title
Prevalence of periodontal pathogens (%) in each group_12 weeks
Description
Four sites will be selected, one per quadrant, based on presence of bleeding during the screening visit. The same sites will be sampled at the follow-up visit. These sites will be isolated with cotton rolls and dried gently with sprayed air. Two consecutive sterile paper points (medium size, Maillefer, Ballaigues, Switzerland) will be inserted as deep as possible into the sulcus, and leave in place for 10 seconds. The paper points will be transferred to a vial containing 1.5 mL of reduced transport fluid (Syed & Loesche, 1972), and pooled with the other paper points. The vial will be sent to the laboratory and processed for culture and qPCR. Prevalence would be defined as presence/absence of each pathogen.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 35-64 years old. Periodontitis patients, already enrolled in a SPT, for at least 6 months, and the last SPT visit in the previous 6 months. Systemically healthy, following the criteria of the American Society of Anesthesiologists (ASA), for patients ASA type I or II (see also exclusion criteria). Presence of at least three evaluable teeth in each quadrant. Moderate gingival inflammation (≥40% bleeding on marginal probing, BOMP) (Van der Weijden, Timmerman, Nijboer, Reijerse, & Van der Velden, 1994) and Turesky plaque index ≥1.5. Also 2017 World Workshop criteria and bleeding on probing (BOP) (Ainamo & Bay, 1975) criteria will be considered. The primary criteria will be BOP ≥30% and Turesky plaque index ≥1.5 No orthodontic banding or removable prosthesis. Subjects willing to participate and comply with the requirements of the study. Complains of dentin hypersensitivity in, at least, one evaluable tooth. Dentin hypersensitivity will be confirmed with evaporative sensitivity (Schiff et al., 1994), with a minimum score of 2-3 (West et al., 2013), although a score of 1 will also be considered as adequate. In order to be eligible, the selected tooth must not have a current desensitizing therapy, must not have been restored in the last 3 moths, or have a crown or a big restoration. Only incisors, canines and premolars will be considered (Holland, Narhi, Addy, Gangarosa, & Orchardson, 1997). Exclusion Criteria: Untreated or uncontrolled periodontitis Regular use of antiseptic-containing and/or anti-hypersensitivity mouth rinses. Antibiotic intake within the previous month. Excessive exposure to acids (eating disorders, chronic regurgitation). Chronic use of analgesic or anti-inflammatory drugs. Pregnant women. Any adverse medical history (diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions. Conditions which requires antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Herrera, Prof
Organizational Affiliation
University Complutense
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Univesity Complutense, Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data would be made available upon a reasonable request

Learn more about this trial

Antiplaque/Antigingivitis Effect of Lacer Oros Integral

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