Effects Of Chlorhexidine Mouthrinse On Peridontopathogens: A Randomized, Placebo-Controlled Study
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01213550 |
|
Recruitment Status :
Completed
First Posted : October 4, 2010
Last Update Posted : October 4, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| 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 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Chlorhexidine |
Drug: Chlorhexidine gluconate |
| Placebo Comparator: Placebo mouthrinse |
Drug: Placebo mouthrinse |
- 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
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.
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): NCT01213550
| Turkey | |
| Ege U School of Dentistry | |
| Izmir, Bornova, Turkey, 35100 | |
| Ege University School of Dentistry Dep of Periodontology | |
| Izmir, Bornova, Turkey, 35100 | |
Publications of Results:
| Responsible Party: | Sema Becerik, Ege |
| ClinicalTrials.gov Identifier: | NCT01213550 History of Changes |
| Other Study ID Numbers: |
07-DIS-27 |
| First Posted: | October 4, 2010 Key Record Dates |
| 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 |