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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Mahidol University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00918060
First received: June 10, 2009
Last updated: October 9, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Periodontitis
Drug: Camella sinensis gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • pocket depth reduction, clinical attachment level gain, gingival index, bleeding score [ Time Frame: baseline, 1, 3 and 6 month after gel had loaded ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plaque index [ Time Frame: baseline, 1, 3, and 6 month after gel had loaded ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: February 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   34 Years to 74 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

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
Study First Received: June 10, 2009
Last Updated: October 9, 2010
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on July 29, 2014