Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis

Phase 2

Completed

• Conditions: Mucositis; Gingivitis
• Interventions: Drug: Chlorhexidine gluconate; Drug: Placebo

• Registration Number: NCT02639377
• Lead Sponsor: Universidade Federal do Rio Grande do Norte

Brief Summary

The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a chemical adjuvant for the treatment of peri-implant mucositis in single implants compared with homologous teeth with gingivitis, in a non-surgical treatment protocol with a six-month follow-up.

Detailed Description

The following clinical parameters were evaluated in both test and control groups; visible plaque index (VPI) and gingival bleeding index (GBI) were obtained for full mouth (IPV and ISG) and for each implant and teeth (VPI implant; VPI teeth; GBI implant; GBI teeth). For statistical purposes, percentages of faces with biofilm and marginal bleeding at teeth and implants were calculated. These parameters were evaluated at baseline and at one, three and six months post-therapy.

Probing depth (PD implant; PD teeth) and bleeding on probing (BOP implant; BOP teeth) were collected for all implants and teeth with a North Carolina periodontal probe at six sites. After data collection, an arithmetic averages of the sites with bleeding on probing and probing depths were calculated at baseline, three and six months. The peri-implant and periodontal biotype for each implant and teeth was rated as thin or thick, according to probe transparency during probing depth.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-21
• Last Update Submitted: 2015-12-21
• Study First Posted: 2015-12-24
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Systemically-healthy partially edentulous patients rehabilitated with functional dental implants and prostheses for at least 1 year;
• Patients had been diagnosed with peri-implant mucositis, probing depth up to 5 mm, bleeding on probing and no radiographic evidence of bone loss beyond the first two threads of the implant;
• Patients had been diagnosed with gingivitis in homologous teeth to implants.

Exclusion Criteria

• Non-smokers and not in maintenance therapy;
• Periodontal treatment during the last six months;
• Have not used antimicrobial (systemic or topical), anti-inflammatory or immunosuppressive drugs during the six months preceding the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine gluconate	Chlorhexidine gluconate	15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days
Placebo	Placebo	15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days

Primary Outcome Measures

Name	Time	Method
Bleeding on probing	six months

Secondary Outcome Measures

Name	Time	Method
Probing depth	baseline and at three and six months