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Effects of a 0.03% CHX Mouth Rinse in Peri-implant Mucositis

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Chlorhexidine
Placebo
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis focused on measuring Peri-implant mucositis, Chlorhexidine, CPC, Treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • the presence of, at least, one dental implant with clinical signs of peri-implant mucositis, defined as gently bleeding on probing (BOP) and/or suppuration without progressive radiographic bone loss (after at least 1 year of functional loading)

Exclusion Criteria:

  • untreated or recurrent periodontitis [presence of nine or more sites with PD 5 mm and with full mouth bleeding score (FMBS) > 25%];
  • implants affected by peri-implantitis, (BOP and/or suppuration and progressive radiographic bone loss);
  • removable implant-retained prosthesis;
  • history of intake of systemic antibiotics within the previous month or other chronic systemic medications that could interfere with the study outcomes;
  • and women being pregnant or breast-feeding.

Sites / Locations

  • Faculty of Dentistry, Univesity Complutense, Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chlorhexidine

Placebo

Arm Description

Mechanical treatment + 0.03% chlorhexidine + 0.05% CPC mouthrinse

Mechanical treatment + Placebo mouth rinse

Outcomes

Primary Outcome Measures

Change on bleeding on probing on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. Primary outcome would be considered for the change between baseline and 12 months One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).

Secondary Outcome Measures

Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Bleeding on probing (BOP) on implants
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Bleeding on probing (BOP) on teeth
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Bleeding on probing (BOP) on teeth
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Bleeding on probing (BOP) on teeth
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Plaque on implants
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987): Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant; Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Plaque on implants
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987): Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant; Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Plaque on implants
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987): Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant; Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Plaque on teeth
Modified plaque index (MPlI) measured at six sites per tooth Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Plaque on teeth
Modified plaque index (MPlI) measured at six sites per tooth Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Plaque on teeth
Modified plaque index (MPlI) measured at six sites per tooth Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Probing depth on implants
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant). One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Probing depth on implants
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant). One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Probing depth on implants
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant). One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Probing depth on teeth
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth). One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Probing depth on teeth
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth). One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Probing depth on teeth
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth). One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Crown-length implant
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site. One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Crown-length implant
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site. One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Crown-length implant
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site. One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Recession on teeth
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction. One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Recession on teeth
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction. One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Recession on teeth
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction. One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Microbiological outcomes_total counts
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient. Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed & Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media. Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Microbiological outcomes_total counts
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient. Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed & Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media. Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Microbiological outcomes_total counts
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient. Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed & Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media. Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Microbiological outcomes_frequency of detection
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Microbiological outcomes_frequency of detection
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Microbiological outcomes_frequency of detection
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Microbiological outcomes_proportions
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Microbiological outcomes_proportions
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Microbiological outcomes_proportions
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Radiographic bone loss on implants
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL). Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image). After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Radiographic bone loss on implants
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL). Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image). After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Radiographic bone loss on implants
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL). Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image). After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Staining
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Staining
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Staining
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Adverse effect
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)
Adverse effect
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)
Adverse effect
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)

Full Information

First Posted
April 18, 2018
Last Updated
May 22, 2018
Sponsor
Universidad Complutense de Madrid
Collaborators
Dentaid SL
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1. Study Identification

Unique Protocol Identification Number
NCT03533166
Brief Title
Effects of a 0.03% CHX Mouth Rinse in Peri-implant Mucositis
Official Title
Clinical and Microbiological Effects of a 0.03% Chlorhexidine Mouth Rinse in the Prevention of Peri-implant Diseases: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 4, 2015 (Actual)
Primary Completion Date
March 25, 2017 (Actual)
Study Completion Date
April 7, 2017 (Actual)

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
Aim: To evaluate the efficacy of a 0.03% chlorhexidine (CHX) and 0.05% cetyl pyridinium chloride (CPC) mouth rinse, as an adjunct to professionally and patient-administered mechanical plaque removal, in the treatment of peri-implant mucositis. Material and Methods: Patients displaying peri-implant mucositis in, at least, one implant were included in this randomized, double-blinded, clinical trial. Subjects received a conventional professional prophylaxis (at baseline and 6-month visits) and were instructed to regular oral hygiene practices and to rinse, twice daily, during one year, with a 0.03% CHX and 0.05% CPC mouth rinse, or a placebo. Clinical, radiographic and microbiological data were recorded at baseline, 6 and 12 months. Disease resolution was defined as the absence of bleeding on probing (BOP). Repeated measures ANOVA, Student-t and chi square tests were used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis
Keywords
Peri-implant mucositis, Chlorhexidine, CPC, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine
Arm Type
Experimental
Arm Description
Mechanical treatment + 0.03% chlorhexidine + 0.05% CPC mouthrinse
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Mechanical treatment + Placebo mouth rinse
Intervention Type
Other
Intervention Name(s)
Chlorhexidine
Intervention Description
0.03% Chlorhexidine + 0.05% CPC mouth rinse
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo mouth rinse
Primary Outcome Measure Information:
Title
Change on bleeding on probing on implants
Description
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. Primary outcome would be considered for the change between baseline and 12 months One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time Frame
Change baseline-12 months
Secondary Outcome Measure Information:
Title
Bleeding on probing (BOP) on implants
Description
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time Frame
Baseline
Title
Bleeding on probing (BOP) on implants
Description
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time Frame
3 months
Title
Bleeding on probing (BOP) on implants
Description
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time Frame
6 months
Title
Bleeding on probing (BOP) on implants
Description
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time Frame
9 months
Title
Bleeding on probing (BOP) on implants
Description
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
Time Frame
12 months
Title
Bleeding on probing (BOP) on teeth
Description
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
Baseline
Title
Bleeding on probing (BOP) on teeth
Description
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
6 months
Title
Bleeding on probing (BOP) on teeth
Description
Bleeding on probing (BOP) on teeth, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing One blinded and calibrated investigator recorded BOP at 6 sites around all teeth, using aPCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
12 months
Title
Plaque on implants
Description
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987): Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant; Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Time Frame
Baseline
Title
Plaque on implants
Description
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987): Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant; Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Time Frame
6 months
Title
Plaque on implants
Description
Modified plaque index (MPlI) measured at six sites per implant (Mombelli et al. 1987): Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the implant; Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.79 for MPlI.
Time Frame
12 months
Title
Plaque on teeth
Description
Modified plaque index (MPlI) measured at six sites per tooth Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
Baseline
Title
Plaque on teeth
Description
Modified plaque index (MPlI) measured at six sites per tooth Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
6 months
Title
Plaque on teeth
Description
Modified plaque index (MPlI) measured at six sites per tooth Score 0: no plaque detected; Score 1: plaque only recognized by running the periodontal probe across the smooth marginal surface of the tooth Score 2: plaque can be seen by the naked eye; Score 3: abundance of soft matter. One blinded and calibrated investigator recorded MPI at 6 sites around teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
12 months
Title
Probing depth on implants
Description
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant). One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Time Frame
Baseline
Title
Probing depth on implants
Description
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant). One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Time Frame
6 months
Title
Probing depth on implants
Description
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the peri-implant mucosal margin (six sites per implant). One blinded and calibrated investigator recorded PD at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient (ICC)=0.93 for PD.
Time Frame
12 months
Title
Probing depth on teeth
Description
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth). One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
Baseline
Title
Probing depth on teeth
Description
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth). One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
6 months
Title
Probing depth on teeth
Description
Probing depth (PD) defined as the distance in mm, between the bottom of the pocket and the gingival margin (six sites per tooth). One blinded and calibrated investigator recorded PD at 6 sites around all teeth, using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
12 months
Title
Crown-length implant
Description
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site. One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Time Frame
Baseline
Title
Crown-length implant
Description
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site. One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Time Frame
6 months
Title
Crown-length implant
Description
Crown-length implant (CLI), defined as the distance in mm, between the incisal/occlusal portion of the crown and the peri-implant mucosal margin at the mid-buccal site. One blinded and calibrated investigator recorded CLI around the selected implant, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA). Calibration was achieved in double measurement calibration sessions, with a gold standard , on six randomly selected patients within one week. The inter-examiner agreement resulted in a intraclass correlation coefficient of 0.96 for CLI.
Time Frame
12 months
Title
Recession on teeth
Description
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction. One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
Baseline
Title
Recession on teeth
Description
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction. One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
6 months
Title
Recession on teeth
Description
Recession (REC), defined as the distance in mm, between the gingival margin and the cements-enamel junction. One blinded and calibrated investigator recorded REC around all teeth using a PCP15 periodontal probe (HuFriedy® , Chicago, IL, USA).
Time Frame
12 months
Title
Microbiological outcomes_total counts
Description
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient. Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed & Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media. Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Time Frame
Baseline
Title
Microbiological outcomes_total counts
Description
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient. Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed & Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media. Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Time Frame
6 months
Title
Microbiological outcomes_total counts
Description
Pooled subgingival samples were obtained from the two most inflamed accessible sites of the selected implant in each patient. Samples were taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 10 s and then transferred into a screw-capped vial containing 1.5 ml of reduced transport fluid (RTF) (Syed & Loesche 1972). Samples were transported to the microbiology laboratory within 2 h, where aliquots of 0.1 mL were plated in different culture media. Counts were transformed in colony-forming units (CFU) per mL of the original sample. Total anaerobic counts and counts of selected periodontal pathogens (A. actinomycetemcomitans, Tannerella forsythia, Porphyromonas gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Eikenella corrodens, Campylobacter rectus and Fusobacterium nucleatum) were calculated.
Time Frame
12 months
Title
Microbiological outcomes_frequency of detection
Description
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Time Frame
Baseline
Title
Microbiological outcomes_frequency of detection
Description
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Time Frame
6 months
Title
Microbiological outcomes_frequency of detection
Description
The frequency of detection was calculated as presence/absence of each periodontal pathogen
Time Frame
12 months
Title
Microbiological outcomes_proportions
Description
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Time Frame
Baseline
Title
Microbiological outcomes_proportions
Description
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Time Frame
6 months
Title
Microbiological outcomes_proportions
Description
The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.
Time Frame
12 months
Title
Radiographic bone loss on implants
Description
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL). Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image). After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Time Frame
Baseline
Title
Radiographic bone loss on implants
Description
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL). Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image). After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Time Frame
3 months
Title
Radiographic bone loss on implants
Description
Standardized periapical radiographs using the parallel technique (Rinn® system, Dentsply, Weybridge, United Kingdom) were used to evaluate changes in the radiographic marginal bone levels (MBL). Scanned images were measured both at the mesial and distal sites using as landmarks the implant shoulder and the first bone implant contact (BIC) of the selected implant using an image analysis software (J-image). After a session of calibration (ICC=0.99), two investigators performed all the radiographic measurements.
Time Frame
12 months
Title
Staining
Description
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Time Frame
Baseline
Title
Staining
Description
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Time Frame
6 months
Title
Staining
Description
Staining of teeth will be scored using the Gründemann modification of the stain index (GMSI) (Grundemann et al. 2000), recorded at nine areas per tooth (three mesial, three medial, three distal). Stain will be graded using the intensity stain index of Lobene (1968).
Time Frame
12 months
Title
Adverse effect
Description
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)
Time Frame
Baseline
Title
Adverse effect
Description
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)
Time Frame
6 months
Title
Adverse effect
Description
A questionnaire will be filled to assess the patient-based variables and side effects, by the patients. They will be evaluated with a visual analogue scale (0-10)
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: the presence of, at least, one dental implant with clinical signs of peri-implant mucositis, defined as gently bleeding on probing (BOP) and/or suppuration without progressive radiographic bone loss (after at least 1 year of functional loading) Exclusion Criteria: untreated or recurrent periodontitis [presence of nine or more sites with PD 5 mm and with full mouth bleeding score (FMBS) > 25%]; implants affected by peri-implantitis, (BOP and/or suppuration and progressive radiographic bone loss); removable implant-retained prosthesis; history of intake of systemic antibiotics within the previous month or other chronic systemic medications that could interfere with the study outcomes; and women being pregnant or breast-feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariano Sanz, Doctor
Organizational Affiliation
University Complutense Madrid (UCM)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Herrera, Doctor
Organizational Affiliation
University Complutense Madrid
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
Citations:
PubMed Identifier
32737664
Citation
Bollain J, Pulcini A, Sanz-Sanchez I, Figuero E, Alonso B, Sanz M, Herrera D. Efficacy of a 0.03% chlorhexidine and 0.05% cetylpyridinium chloride mouth rinse in reducing inflammation around the teeth and implants: a randomized clinical trial. Clin Oral Investig. 2021 Apr;25(4):1729-1741. doi: 10.1007/s00784-020-03474-3. Epub 2020 Jul 31.
Results Reference
derived
PubMed Identifier
30779246
Citation
Pulcini A, Bollain J, Sanz-Sanchez I, Figuero E, Alonso B, Sanz M, Herrera D. Clinical effects of the adjunctive use of a 0.03% chlorhexidine and 0.05% cetylpyridinium chloride mouth rinse in the management of peri-implant diseases: A randomized clinical trial. J Clin Periodontol. 2019 Mar;46(3):342-353. doi: 10.1111/jcpe.13088.
Results Reference
derived

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Effects of a 0.03% CHX Mouth Rinse in Peri-implant Mucositis

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