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

Primary Purpose

Mucositis, Gingivitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chlorhexidine gluconate
Placebo
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis focused on measuring Dental Implantation, Chlorhexidine gluconate

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Chlorhexidine gluconate

    Placebo

    Arm Description

    15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days

    15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days

    Outcomes

    Primary Outcome Measures

    Bleeding on probing
    Bleeding on probing
    Bleeding on probing

    Secondary Outcome Measures

    Probing depth

    Full Information

    First Posted
    December 21, 2015
    Last Updated
    December 21, 2015
    Sponsor
    Universidade Federal do Rio Grande do Norte
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02639377
    Brief Title
    Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis
    Official Title
    Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis: a Randomised Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio Grande do Norte

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mucositis, Gingivitis
    Keywords
    Dental Implantation, Chlorhexidine gluconate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Chlorhexidine gluconate
    Arm Type
    Experimental
    Arm Description
    15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Chlorhexidine gluconate
    Other Intervention Name(s)
    Chlorhexidine
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    placebo solution
    Intervention Description
    Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash
    Primary Outcome Measure Information:
    Title
    Bleeding on probing
    Time Frame
    baseline
    Title
    Bleeding on probing
    Time Frame
    three months
    Title
    Bleeding on probing
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    Probing depth
    Time Frame
    baseline and at three and six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bruno CV Gurgel, Doctor
    Organizational Affiliation
    Universidade Federal do Rio Grande do Norte
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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