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

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ClinicalTrials.gov Identifier: NCT02639377
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Karyna de Melo Menezes, Universidade Federal do Rio Grande do Norte

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.

Condition or disease Intervention/treatment Phase
Mucositis Gingivitis Drug: Chlorhexidine gluconate Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis: a Randomised Controlled Clinical Trial
Study Start Date : October 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013


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 Name: 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 Name: placebo solution




Primary Outcome Measures :
  1. Bleeding on probing [ Time Frame: baseline ]
  2. Bleeding on probing [ Time Frame: three months ]
  3. Bleeding on probing [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Probing depth [ Time Frame: baseline and at three and six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639377


Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Investigators
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Study Director: Bruno CV Gurgel, Doctor Universidade Federal do Rio Grande do Norte
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Responsible Party: Karyna de Melo Menezes, Principal Investigator, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT02639377    
Other Study ID Numbers: UFRN-2
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Karyna de Melo Menezes, Universidade Federal do Rio Grande do Norte:
Dental Implantation
Chlorhexidine gluconate
Additional relevant MeSH terms:
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Mucositis
Gingivitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents