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

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:

Drug Information available for: Chlorhexidine Chlorhexidine acetate Chlorhexidine hydrochloride Chlorhexidine gluconate Hibiclens

U.S. FDA Resources

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 (Adult)
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

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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:

Türkoğlu O, Becerik S, Emingil G, Kütükçüler N, Baylas H, Atilla G. The effect of adjunctive chlorhexidine mouthrinse on clinical parameters and gingival crevicular fluid cytokine levels in untreated plaque-associated gingivitis. Inflamm Res. 2009 May;58(5):277-83. doi: 10.1007/s00011-008-8129-z.


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 Disinfectants Dermatologic Agents

ClinicalTrials.gov processed this record on September 23, 2016