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

Peri-implant Mucositis Clinical Trial

Official title:

Clinical and Microbiological Effects of a 0.03% Chlorhexidine Mouth Rinse in the Prevention of Peri-implant Diseases: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533166
• Other study ID #: 15/064
• Status: Completed
• Phase: N/A
• Start date: November 4, 2015
• Est. completion date: April 7, 2017

Study information

• Verified date: April 2018
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 7, 2017
• Est. primary completion date: March 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

Other:
• Chlorhexidine
0.03% Chlorhexidine + 0.05% CPC mouth rinse
• Placebo
Placebo mouth rinse

Locations

Country	Name	City	State
Spain	Faculty of Dentistry, Univesity Complutense, Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Dentaid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change baseline-12 months
Secondary	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).	Baseline
Secondary	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).	3 months
Secondary	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).	6 months
Secondary	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).	9 months
Secondary	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).	12 months
Secondary	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).	Baseline
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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).	Baseline
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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).	Baseline
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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).	Baseline
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	Microbiological outcomes_frequency of detection	The frequency of detection was calculated as presence/absence of each periodontal pathogen	Baseline
Secondary	Microbiological outcomes_frequency of detection	The frequency of detection was calculated as presence/absence of each periodontal pathogen	6 months
Secondary	Microbiological outcomes_frequency of detection	The frequency of detection was calculated as presence/absence of each periodontal pathogen	12 months
Secondary	Microbiological outcomes_proportions	The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.	Baseline
Secondary	Microbiological outcomes_proportions	The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.	6 months
Secondary	Microbiological outcomes_proportions	The proportions for each bacterial species was calculated by dividing the counts of each pathogen by the total counts.	12 months
Secondary	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.	Baseline
Secondary	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.	3 months
Secondary	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.	12 months
Secondary	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).	Baseline
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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)	Baseline
Secondary	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)	6 months
Secondary	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)	12 months