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

NCT ID: NCT02639377

Last Updated: 2015-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Mucositis; Gingivitis

Keywords

Dental Implantation; Chlorhexidine gluconate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chlorhexidine gluconate

15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days

Group Type: EXPERIMENTAL

Chlorhexidine gluconate

Intervention Type: DRUG

Placebo

15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash

Interventions

Chlorhexidine gluconate

Intervention Type: DRUG

Placebo

Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash

Intervention Type: DRUG

Other Intervention Names

Chlorhexidine; placebo solution

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Karyna de Melo Menezes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruno CV Gurgel, Doctor

Role: STUDY_DIRECTOR

Universidade Federal do Rio Grande do Norte

Other Identifiers

UFRN-2

Identifier Type: -

Identifier Source: org_study_id