Skip to main content
OpenTrials
Completed

NCT Number: NCT02639377

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chlorhexidine gluconate

Drug

Other names: Chlorhexidine

Placebo

Drug

Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash

Other names: placebo solution

Primary outcomes

  1. Bleeding on probing

    Time frame: baseline

  2. Bleeding on probing

    Time frame: three months

  3. Bleeding on probing

    Time frame: six months

Secondary outcomes

  1. Probing depth

    Time frame: baseline and at three and six months

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 24, 2015
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.