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

December 21, 2015 updated by: Karyna de Melo Menezes, Universidade Federal do Rio Grande do Norte

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: baseline
baseline
Bleeding on probing
Time Frame: three months
three months
Bleeding on probing
Time Frame: six months
six months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio Grande do Norte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFRN-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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