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

NCT03533166 | Completed

• 1 other identifier: 15/064
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Mucositis

Keywords

Peri-implant mucositis; Chlorhexidine; CPC; Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (44)

• Bleeding on probing (BOP) on implants

  Baseline

• Bleeding on probing (BOP) on implants

  3 months

• Bleeding on probing (BOP) on implants

  6 months

• Bleeding on probing (BOP) on implants

  9 months

• Bleeding on probing (BOP) on implants

  12 months

Study Arms (2)

Chlorhexidine

EXPERIMENTAL

Mechanical treatment + 0.03% chlorhexidine + 0.05% CPC mouthrinse

Other: Chlorhexidine

Placebo

PLACEBO COMPARATOR

Mechanical treatment + Placebo mouth rinse

Other: Placebo

Interventions

Chlorhexidine OTHER

0.03% Chlorhexidine + 0.05% CPC mouth rinse

Chlorhexidine

Placebo OTHER

Placebo mouth rinse

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Dentaid SL: collaborator

Study Sites (1)

Faculty of Dentistry, Univesity Complutense, Madrid

Madrid, 28040, Spain

Location

Related Publications (2)

• 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.

  PMID: 32737664 DERIVED

• 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.

  PMID: 30779246 DERIVED

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Mariano Sanz, Doctor

  University Complutense Madrid (UCM)

  PRINCIPAL INVESTIGATOR

• David Herrera, Doctor

  University Complutense Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 23, 2018
• Study Start: November 4, 2015
• Primary Completion: March 25, 2017
• Study Completion: April 7, 2017
• Last Updated: May 23, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)