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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02639377
Enrollment
29
Registered
2015-12-24
Start date
2012-10-31
Completion date
2013-12-31
Last updated
2015-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Mucositis

Keywords

Dental Implantation, Chlorhexidine gluconate

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.

Interventions

DRUGChlorhexidine gluconate
DRUGPlacebo

Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash

Sponsors

Universidade Federal do Rio Grande do Norte
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Bleeding on probingbaseline

Secondary

MeasureTime frame
Probing depthbaseline and at three and six months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026