Effects Of Chlorhexidine Mouthrinse On Peridontopathogens: A Randomized, Placebo-Controlled Study

This study has been completed.
Sponsor:
Information provided by:
Ege University
ClinicalTrials.gov Identifier:
NCT01213550
First received: October 1, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

The aim of this study is to evaluate the therapeutic effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control in a population with established gingivitis.


Condition Intervention Phase
This Study Evaluated the Effectiveness of Chlorhexidine Mouthrinse on Subgingival Microbiota
Drug: Chlorhexidine gluconate
Drug: Placebo mouthrinse
Phase 4

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Ege University:

Primary Outcome Measures:
  • effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control
  • effectiveness of chlorhexidine mouthrinse subgingival microbiota in addition to daily mechanical plaque control

Enrollment: 50
Study Start Date: March 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chlorhexidine Drug: Chlorhexidine gluconate
Placebo Comparator: Placebo mouthrinse Drug: Placebo mouthrinse

Detailed Description:

Failure to perform oral hygiene adequately at the gingival margin results in the formation of a pathogenic plaque that has the potential to initiate gingivitis and in some individuals to progress to periodontitis. However, factors, such as dexterity and motivation, can limit the effectiveness of daily self-performed oral hygiene. The use of a chemical plaque-inhibitory mouthrinse as an adjunct to toothbrushing may improve the oral health of individuals who are inadequate in mechanical plaque control in maintaining gingival health.

Chlorhexidine (CHX) has been effectively used in the treatment of gingival inflammation and can be considered as the gold standard for oral antiseptics.

The effectiveness of CHX in reducing the formation of dental plaque and preventing gingivitis in addition to professional mechanical debridement were studied in several clinical studies, but there is limited number of studies investigating the effects of CHX on untreated gingivitis and subgingival microbiota.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 18-45 years old male or female with gingivitis associated with dental plaque, no clinical signs of destructive periodontal disease, clinical attachment loss < 3mm, a minimum of 20 teeth (teeth that have gross caries, were fully crowned or extensively restored, orthodontic banded, abutments, or third molars were not included in the tooth count).

Exclusion Criteria:

  • use of tobacco products, history or current manifestation of systemic disease which could impair immune response such as diabetes mellitus, immunological disorders, hepatitis and HIV infections, use of antibiotic or anti-inflammatory or immunosuppressive drugs during 3 months period prior to the start of the trial, periodontal therapy during the last 3 month, pregnancy or lactation and oral contraceptives usage.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213550

Locations
Turkey
Ege U School of Dentistry
Izmir, Bornova, Turkey, 35100
Ege University School of Dentistry Dep of Periodontology
Izmir, Bornova, Turkey, 35100
Sponsors and Collaborators
Ege University
  More Information

Publications:
Responsible Party: Sema Becerik, Ege
ClinicalTrials.gov Identifier: NCT01213550     History of Changes
Other Study ID Numbers: 07-DIS-27
Study First Received: October 1, 2010
Last Updated: October 1, 2010
Health Authority: Turkey: ethics committee of the Ege University School of Medicine

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on July 22, 2014