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Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts as an Adjunct in Peridontitis Treatment

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ClinicalTrials.gov Identifier: NCT00918060
Recruitment Status : Unknown
Verified October 2010 by Mahidol University.
Recruitment status was:  Active, not recruiting
First Posted : June 11, 2009
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Mahidol University

Brief Summary:
The purpose of this study is to evaluate clinical result including plaque index, gingival inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in periodontal therapy

Condition or disease Intervention/treatment Phase
Periodontitis Drug: Camella sinensis gel Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts
Study Start Date : February 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: gel a Drug: Camella sinensis gel
clinical effect of locally-delivered gel between Camella sinensis and placebo
Placebo Comparator: gel b Drug: Camella sinensis gel
clinical effect of locally-delivered gel between Camella sinensis and placebo



Primary Outcome Measures :
  1. pocket depth reduction, clinical attachment level gain, gingival index, bleeding score [ Time Frame: baseline, 1, 3 and 6 month after gel had loaded ]

Secondary Outcome Measures :
  1. plaque index [ Time Frame: baseline, 1, 3, and 6 month after gel had loaded ]


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Ages Eligible for Study:   34 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • subjects have sound tooth with pocket depth = or > 5 mm. without caries, restoration, mobility and furcation involvement
  • no systemic complicated factors
  • no allergy to green tea or product of green tea
  • signing in informed consent form

Exclusion Criteria:

  • smoking
  • pregnancy or lactation
  • antibiotic premedication or antibiotic intake in previous 3 month

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): NCT00918060


Sponsors and Collaborators
Mahidol University
Investigators
Study Director: Kanyawat Rattanasuwan Department of Oral Medicine, Mahidol University
Study Chair: Kanyawat Rattanasuwan Maha Chakri Sirindhorn Dental Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kanyawat Rattanasuwan, Department of Oral Medicine, Mahidol University
ClinicalTrials.gov Identifier: NCT00918060     History of Changes
Other Study ID Numbers: COA. No. MU-IRB 2008/153.0511
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases