Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis
Condition: Mucositis
MeSH terms: Mucositis
Study type: Interventional
Phase: Phase 2

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 a non-surgical treatment
      protocol with a six-month follow-up.
    

Detailed description: 
      Determination of the sample size was based on the sample calculation for clinical trials,
      estimating a 50% success rate for the control group and 100% for the test group, which was
      then averaged for the two groups. With a standardized difference and power test of 85%, a
      total of 28 subjects per group were obtained.

      Periapical radiographic examinations were performed before the collection of data to confirm
      the absence of bone loss, and threads exposition of the implants. 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
      (VPI implant; GBI implant). 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.

      Keratinized mucosa width (KM), probing depth (PD implant), and bleeding on probing (BOP
      implant) were collected for all implants with a North Carolina periodontal probe at six
      sites. After data collection, an arithmetic averages of the sites with bleeding on probing,
      probing depths, and keratinized mucosa were calculated at baseline, three and six months. The
      peri-implant biotype for each implant was rated as thin or thick, according to probe
      transparency during probing depth.

      Clinical parameters were collected by two operators, calibrated by the Kappa test for the
      keratinized mucosa, peri-implant biotype and probing depth.

      After inclusion of the patients, anamnesis and initial examination were performed. The
      subjects were randomly divided, using a simple draw, in the following two groups: Test -
      (0.12% chlorhexidine digluconate associated with periodontal basic therapy) and Control -
      (placebo associated with periodontal basic therapy). Data were analyzed using descriptive and
      inferential statistics, with nonparametric tests, through a Statistical Package Social
      Sciences software (SPSS), version 17.0 (free version). The Friedman test was used for
      intragroup analysis and if any significant differences were observed, the Wilcoxon post-test
      was performed. Additionally, Mann-Whitney test was used for intergroup analysis. Chi-Square
      test was used to evaluate probing depth and bleeding on probing, according to the independent
      variables of interest: age, sex, treatment group, keratinized mucosa, peri-implant biotype,
      median VPI implant and GBI implant. Spearman correlation was also used to correlate probing
      depth and bleeding on probing after six months of follow-up. The implant was considered the
      unit of analysis and a value of p<0.05 was used to represent a statistically significant
      difference.
    

Intervention name(s): Chlorhexidine gluconate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash
Other intervention name(s): Chlorhexidine; placebo solution
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dental Implantation; Chlorhexidine gluconate