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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02639377
• Other study ID #: UFRN-2
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2015
• Last updated: December 21, 2015
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis
• Mucositis

Intervention

Drug:
• Chlorhexidine gluconate

• Placebo
Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on probing		baseline	No
Primary	Bleeding on probing		three months	No
Primary	Bleeding on probing		six months	No
Secondary	Probing depth		baseline and at three and six months	No