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

Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis: a Randomised Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Mucositis
• Intervention / Treatment: Drug: Chlorhexidine gluconate; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Chlorhexidine gluconate; 15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days	Drug: Chlorhexidine gluconate; Other Names: Chlorhexidine
PLACEBO_COMPARATOR: Placebo; 15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days	Drug: Placebo; Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash; Other Names: placebo solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bleeding on probing	baseline
Bleeding on probing	three months
Bleeding on probing	six months

Secondary Outcome Measures

Outcome Measure	Time Frame
Probing depth	baseline and at three and six months

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: December 21, 2015
• First Posted (ESTIMATE): December 24, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): December 24, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Chlorhexidine gluconate; Dental Implantation
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Mucositis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: UFRN-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO