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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
This Study Evaluated the Effectiveness of Chlorhexidine Mouthrinse on Subgingival Microbiota	Drug: Chlorhexidine gluconate; Drug: Placebo mouthrinse	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Study Start Date :	March 2006
Actual Primary Completion Date :	December 2007
Actual Study Completion Date :	December 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Chlorhexidine	Drug: Chlorhexidine gluconate
Placebo Comparator: Placebo mouthrinse	Drug: Placebo mouthrinse

Outcome Measures

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Primary Outcome Measures :

1. effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control
2. effectiveness of chlorhexidine mouthrinse subgingival microbiota in addition to daily mechanical plaque control

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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
First Posted:	October 4, 2010
Last Update Posted:	October 4, 2010
Last Verified:	October 2010

Additional relevant MeSH terms:

Chlorhexidine; Chlorhexidine gluconate; Anti-Infective Agents, Local	Anti-Infective Agents; Disinfectants; Dermatologic Agents