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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mucositis, Gingivitis

Intervention / Treatment
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* Drug: Chlorhexidine gluconate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine gluconate<br>15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days | Drug: Chlorhexidine gluconate<br> <br> * Other names: Chlorhexidine;|
| Placebo Comparator: Placebo<br>15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days | Drug: Placebo<br>* Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash<br>* Other names: placebo solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing |  | baseline | 
| Bleeding on probing |  | three months | 
| Bleeding on probing |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth |  | baseline and at three and six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Implantation, Chlorhexidine gluconate