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Impact of a Newly Formulated Toothpaste in Tooth Staining Associated With Chlorhexidine Rinses (PaSTaining)

Primary Purpose

Tooth Staining, Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)
Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Staining focused on measuring Tooth staining, Periodontitis, Chlorhexidine, tripolyphosphate and polyvinylpyrrolidone (PVP)

Eligibility Criteria

30 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 30-69 years old.
  • Periodontitis patients, in stages I-III, requiring steps 1 and 2 of periodontal treatment including full-mouth subgingival instrumentation.
  • 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.
  • No orthodontic banding or removable prosthesis.
  • Subjects willing to participate and comply with the requirements of the study.

Exclusion Criteria:

  • Acute periodontal conditions.
  • Antibiotic intake within the previous month.
  • 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 require antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).

Sites / Locations

  • Faculty of Dentistry, University Complutense of Madrid (UCM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Control-Control

Control-test

Test-control

Test-test

Arm Description

Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.

Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.

Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.

Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.

Outcomes

Primary Outcome Measures

Tooth Staining
GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine. The zones to be scored, buccal only: Mesial (A), Distal (A), Gingival (G) and Incisal (I) The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968): Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain
Tooth Staining
GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine. The zones to be scored, buccal only: Mesial (A), Distal (A), Gingival (G) and Incisal (I) The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968): Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain

Secondary Outcome Measures

Dental plaque
Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962). Scale: 0-5. Score=0 No Plaque Score=1 The presence of a discontinuous line of plaque at the gingival margin e.g. small islands Score=2 A continuous line of plaque at the gingival margin which does not extend greater than 1 mm from the margin Score=3 Plaque coverage which is greater than 1 mm but does not extend more than one third of the tooth Score=4 Plaque which covers more than one third but not more than two third of the tooth surface Score=5 Plaque coverage over more than two third of the tooth surface.
Dental plaque
Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962) Score=0 No Plaque Score=1 The presence of a discontinuous line of plaque at the gingival margin e.g. small islands Score=2 A continuous line of plaque at the gingival margin which does not extend greater than 1 mm from the margin Score=3 Plaque coverage which is greater than 1 mm but does not extend more than one third of the tooth Score=4 Plaque which covers more than one third but not more than two third of the tooth surface Score=5 Plaque coverage over more than two third of the tooth surface.
Dental plaque
Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962) Score=0 No Plaque Score=1 The presence of a discontinuous line of plaque at the gingival margin e.g. small islands Score=2 A continuous line of plaque at the gingival margin which does not extend greater than 1 mm from the margin Score=3 Plaque coverage which is greater than 1 mm but does not extend more than one third of the tooth Score=4 Plaque which covers more than one third but not more than two third of the tooth surface Score=5 Plaque coverage over more than two third of the tooth surface.
Gingival condition
Gingival Bleeding Index (Ainamo & Bay, 1975)
Gingival condition
Gingival Bleeding Index (Ainamo & Bay, 1975)
Probing depth (PD)
Distance from the gingival margin to the base of the pocket (mm)
Probing depth (PD)
Distance from the gingival margin to the base of the pocket (mm)
Recession (REC)
Distance from the gingival margin to the cemento-enamel junction (mm)
Recession (REC)
Distance from the gingival margin to the cemento-enamel junction (mm)
Patient-reported outcome measures (PROMs)
A predefined questionnaire will be filled by the patient, on product usage and perceptions, and also on possible factors influencing tooth staining, such as the consumption of certain foods and drinks, as well as compliance with product use.
Patient-reported outcome measures (PROMs)
A predefined questionnaire will be filled by the patient, on product usage and perceptions, and also on possible factors influencing tooth staining, such as the consumption of certain foods and drinks, as well as compliance with product use.
Compliance
The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused tubes and mouth rinse bottles. In the compliance forms, information about the number of times a day has the patient used the dentifrices and the rinses during the whole study period will be recorded.
Compliance
The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused tubes and mouth rinse bottles. In the compliance forms, information about the number of times a day has the patient used the dentifrices and the rinses during the whole study period will be recorded.

Full Information

First Posted
April 19, 2022
Last Updated
July 3, 2023
Sponsor
Universidad Complutense de Madrid
Collaborators
Dentaid SL
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1. Study Identification

Unique Protocol Identification Number
NCT05354986
Brief Title
Impact of a Newly Formulated Toothpaste in Tooth Staining Associated With Chlorhexidine Rinses
Acronym
PaSTaining
Official Title
Impact of a Newly Formulated Tooth Paste in the Prevention/Elimination of Tooth Staining Associated With Adjunctive Use Chlorhexidine Mouth Rinses to Subgingival Instrumentation. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Dentaid SL

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
Dental staining may interfere with compliance with chlorhexidine mouth rinse use Thus, developing strategies to control tooth staining associated with chlorhexidine use may be relevant for improving compliance. Thus, a new anti-staining toothpaste formulation (Dentaid, Barcelona, Spain) has been recently developed, aiming to interfere with the development of extrinsic staining associated with chlorhexidine use (preventive action), but also with the capacity of removing staining already formed. For that, the proposed formulation includes hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Thus, it may be relevant to test the efficacy of this new anti-staining toothpaste formulation in two consecutive randomized clinical trials (RCTs). Objectives The primary objective of these RCTs will be to evaluate the capacity of preventing tooth staining, associated with the use of a chlorhexidine mouth rinse, adjunctive to subgingival instrumentation (step 2 of periodontal therapy) (RCT #1). As secondary objective, the capacity of eliminating or reducing tooth staining already present will be assessed (RCT #2).
Detailed Description
The primary objective of these RCTs will be to evaluate the capacity of preventing tooth staining, associated with the use of a chlorhexidine mouth rinse, adjunctive to subgingival instrumentation (step 2 of periodontal therapy) (RCT #1). As secondary objective, the capacity of eliminating or reducing tooth staining already present will be assessed (RCT #2). Additional objectives will include to test: (1) the safety of the tested formulation, in terms of adverse events and tolerability; (2) patient´s evaluation of the product, by means of patient-reported outcome measures (PROMs); and (3) clinical impact of the tested formulation in terms of periodontal clinical outcomes. Consecutive subjects, referred to the Post-Graduate Periodontal Clinic in the University Complutense, Madrid, seeking for treatment of periodontitis in stages I-III will be screened, and enrolled in the clinical trials if they fulfil the following criteria and accept to participate by filling an informed consent Two consecutive parallel, double-blind, randomized, placebo-controlled, 2-week, clinical trials have been designed. Screening visit After completing a questionnaire including the subject's medical health status, medication and smoking habit [smoker defined when currently smoking ≥ 9 cigarettes per day], a careful oral health evaluation will be carried out. If subjects met the inclusion/exclusion criteria, the investigator will inform them about the aims and details of the study and will request their voluntary participation. Once they accept, by signing the Institutional Review Board (IRB) approved informed consent form, they will be enrolled in the study. Pre-treatment visit At this visit the oral health of each participant, identified by a unique trial number, will be examined. Clinical parameters will be recorded around all teeth, except the third molars. Treatment visits All interventions, included in the steps 1 and 2 of periodontal therapy will be implemented according to the patient´s needs. Specifically, subgingival instrumentation will be performed in two sessions, with a maximum interval of one week, with hand and automatic devices, under local anaesthesia. Full-mouth dental polishing (air-polishing) will be performed immediately after the second session, to eliminate any dental staining. Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. Randomization will be performed using true random numbers from a computer-generated list, stratified for tobacco smoking (smokers of 10 or more cigarettes per day versus other smokers, former smokers and non-smokers): The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse, All subjects will be masked to their group allocation and will receive their assigned products kit containing: a manual toothbrush (Vitis Suave, Dentaid, Barcelona, Spain), the test or placebo toothpaste, and the mouth rinse with dose caps. They will be instructed to brush with the toothpaste (the amount of a pee size) for 2 minutes, twice daily, and then rinse for 30 seconds with 15 mL of the mouth rinse, twice daily. Standardized instructions will be given for mechanical supragingival biofilm control, including the use of interdental brushes (Interprox®, Dentaid, Barcelona, Spain). Each subject will receive standardized verbal and written instructions on how to use the assigned products. 2-week visit (final visit, RCT #1; initial visit, RCT #2) Two weeks after the second session of subgingival instrumentation, an oral examination will be performed to evaluate possible adverse effect, and dental plaque index will be recorded. Clinical photographs will be also taken to assess staining (four, for sextants 2 and 5, for buccal and palatal surfaces). The subjects will be asked about the occurrence of any adverse effects. A questionnaire on product usage and perceptions (PROMs), dietary habits and compliance with product use will be filled by the patients. The study coordinator will collect the empty and unused tubes and bottles. Subjects will be provided with a new kit containing the necessary assigned products. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. Thus, at the 2-week visit, half of each group will continue with the same toothpaste and the other half will change toothpaste, creating four different groups, when considering both RCTs: group control-control, group control-test, group test-control, group test-test) 4-week visit (final visit, RCT #2) After 4 weeks, a comprehensive oral examination will be performed, including the assessment of clinical variables. The subjects will be asked about the occurrence of any adverse effects and the study coordinator will collect the empty and unused tubes. A new questionnaire on product usage and perceptions (PROMs), dietary habits and compliance with product use will be filled by the patients. Clinical photographs (four, for sextants 2 and 5, for buccal and palatal surfaces) will be also taken to assess staining. All subjects will be provided with a professional dental prophylaxis at the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Staining, Periodontitis
Keywords
Tooth staining, Periodontitis, Chlorhexidine, tripolyphosphate and polyvinylpyrrolidone (PVP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Two consecutive parallel, double-blind, randomized, placebo-controlled, 2-week, clinical trials
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
test and placebo toothpastes would be identical
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control-Control
Arm Type
Placebo Comparator
Arm Description
Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.
Arm Title
Control-test
Arm Type
Experimental
Arm Description
Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
Arm Title
Test-control
Arm Type
Experimental
Arm Description
Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The control group will use three times daily a provided manual toothbrush with the placebo toothpaste (identical to the test tooth paste, but without the active ingredients), followed by the use, twice daily, of a 0.12% chlorhexidine mouth rinse.
Arm Title
Test-test
Arm Type
Experimental
Arm Description
Immediately after the second session of subgingival instrumentation (initial visit, RCT #1) subjects will be randomly assigned to one of two groups, test or placebo. 0-2 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse. Subjects will stop using the mouth rinse, and will start the second RCT, being randomized again, within each group of the first RCT, to the placebo or test toothpaste. 2-4 weeks: The experimental group will use three times daily a provided manual toothbrush with the test toothpaste (Dentaid, Barcelona, Spain), followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
Intervention Type
Other
Intervention Name(s)
Toothpaste with hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)
Intervention Description
Subgingival instrumentation will be performed in two sessions, with a maximum interval of one week, with hand and automatic devices, under local anaesthesia. Full-mouth dental polishing (air-polishing) will be performed immediately after the second session, to eliminate any dental staining. Experimental anti-staining toothpaste formulation (Dentaid, Barcelona, Spain) includes hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Participants will use the test or control toothpaste three times daily with a manual toothbrush followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
Intervention Type
Other
Intervention Name(s)
Toothpaste without hexametaphosphate, tripolyphosphate and polyvinylpyrrolidone (PVP)
Intervention Description
Subgingival instrumentation will be performed in two sessions, with a maximum interval of one week, with hand and automatic devices, under local anaesthesia. Full-mouth dental polishing (air-polishing) will be performed immediately after the second session, to eliminate any dental staining. Experimental anti-staining toothpaste formulation without tripolyphosphate and polyvinylpyrrolidone (PVP), within its ingredients. Participants will use the test or control toothpaste three times daily with a manual toothbrush followed by the use, twice daily, of a 0.12% chlorhexidine, commercially available, mouth rinse.
Primary Outcome Measure Information:
Title
Tooth Staining
Description
GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine. The zones to be scored, buccal only: Mesial (A), Distal (A), Gingival (G) and Incisal (I) The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968): Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain
Time Frame
2 weeks
Title
Tooth Staining
Description
GRÜNDEMANN MODIFIED STAIN INDEX (GMSI) (Gründemann et al., 2000). 2. Photographs of buccal and lingual/palatal areas of lower and upper anterior teeth, from canine to canine. The zones to be scored, buccal only: Mesial (A), Distal (A), Gingival (G) and Incisal (I) The intensity in each zone will be scored using the following criteria described by Lobene (Lobene, 1968): Score=0 No stain Score=1 Light stain Score=2 Moderate stain Score=3 Heavy stain
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Dental plaque
Description
Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962). Scale: 0-5. Score=0 No Plaque Score=1 The presence of a discontinuous line of plaque at the gingival margin e.g. small islands Score=2 A continuous line of plaque at the gingival margin which does not extend greater than 1 mm from the margin Score=3 Plaque coverage which is greater than 1 mm but does not extend more than one third of the tooth Score=4 Plaque which covers more than one third but not more than two third of the tooth surface Score=5 Plaque coverage over more than two third of the tooth surface.
Time Frame
0 weeks
Title
Dental plaque
Description
Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962) Score=0 No Plaque Score=1 The presence of a discontinuous line of plaque at the gingival margin e.g. small islands Score=2 A continuous line of plaque at the gingival margin which does not extend greater than 1 mm from the margin Score=3 Plaque coverage which is greater than 1 mm but does not extend more than one third of the tooth Score=4 Plaque which covers more than one third but not more than two third of the tooth surface Score=5 Plaque coverage over more than two third of the tooth surface.
Time Frame
2 weeks
Title
Dental plaque
Description
Turesky et al. (Turesky, Gilmore, & Glickman, 1970) modification of the Quigley and Hein index (Quigley & Hein, 1962) Score=0 No Plaque Score=1 The presence of a discontinuous line of plaque at the gingival margin e.g. small islands Score=2 A continuous line of plaque at the gingival margin which does not extend greater than 1 mm from the margin Score=3 Plaque coverage which is greater than 1 mm but does not extend more than one third of the tooth Score=4 Plaque which covers more than one third but not more than two third of the tooth surface Score=5 Plaque coverage over more than two third of the tooth surface.
Time Frame
4 weeks
Title
Gingival condition
Description
Gingival Bleeding Index (Ainamo & Bay, 1975)
Time Frame
0 weeks
Title
Gingival condition
Description
Gingival Bleeding Index (Ainamo & Bay, 1975)
Time Frame
4 weeks
Title
Probing depth (PD)
Description
Distance from the gingival margin to the base of the pocket (mm)
Time Frame
0 weeks
Title
Probing depth (PD)
Description
Distance from the gingival margin to the base of the pocket (mm)
Time Frame
4 weeks
Title
Recession (REC)
Description
Distance from the gingival margin to the cemento-enamel junction (mm)
Time Frame
0 weeks
Title
Recession (REC)
Description
Distance from the gingival margin to the cemento-enamel junction (mm)
Time Frame
4 weeks
Title
Patient-reported outcome measures (PROMs)
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, and also on possible factors influencing tooth staining, such as the consumption of certain foods and drinks, as well as compliance with product use.
Time Frame
2 weeks
Title
Patient-reported outcome measures (PROMs)
Description
A predefined questionnaire will be filled by the patient, on product usage and perceptions, and also on possible factors influencing tooth staining, such as the consumption of certain foods and drinks, as well as compliance with product use.
Time Frame
4 weeks
Title
Compliance
Description
The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused tubes and mouth rinse bottles. In the compliance forms, information about the number of times a day has the patient used the dentifrices and the rinses during the whole study period will be recorded.
Time Frame
2 weeks
Title
Compliance
Description
The study coordinator will collect, at each study visit, the compliance forms, filled by the patients, as well as the empty and unused tubes and mouth rinse bottles. In the compliance forms, information about the number of times a day has the patient used the dentifrices and the rinses during the whole study period will be recorded.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 30-69 years old. Periodontitis patients, in stages I-III, requiring steps 1 and 2 of periodontal treatment including full-mouth subgingival instrumentation. 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. No orthodontic banding or removable prosthesis. Subjects willing to participate and comply with the requirements of the study. Exclusion Criteria: Acute periodontal conditions. Antibiotic intake within the previous month. 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 require antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Herrera, Prof.
Phone
0034913942021
Email
davidher@ucm.es
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Figuero, Prof.
Email
elfiguer@ucm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Herrera, Prof.
Organizational Affiliation
Etiology and Therapy of Periodontal and Periimplant Research Group (ETEP). Faculty of Dentistry. University Complutense of Madrid (UCM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, University Complutense of Madrid (UCM)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Herrera, Prof.
First Name & Middle Initial & Last Name & Degree
Elena Figuero
First Name & Middle Initial & Last Name & Degree
Ana Araoz

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of a Newly Formulated Toothpaste in Tooth Staining Associated With Chlorhexidine Rinses

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