Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts as an Adjunct in Peridontitis Treatment
1 other identifier
interventional
48
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2008
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 10, 2009
CompletedFirst Posted
Study publicly available on registry
June 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedOctober 13, 2010
October 1, 2010
2.8 years
June 10, 2009
October 9, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
pocket depth reduction, clinical attachment level gain, gingival index, bleeding score
baseline, 1, 3 and 6 month after gel had loaded
Secondary Outcomes (1)
plaque index
baseline, 1, 3, and 6 month after gel had loaded
Study Arms (2)
gel a
EXPERIMENTALgel b
PLACEBO COMPARATORInterventions
clinical effect of locally-delivered gel between Camella sinensis and placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- smoking
- pregnancy or lactation
- antibiotic premedication or antibiotic intake in previous 3 month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Rattanasuwan K, Rassameemasmaung S, Sangalungkarn V, Komoltri C. Clinical effect of locally delivered gel containing green tea extract as an adjunct to non-surgical periodontal treatment. Odontology. 2016 Jan;104(1):89-97. doi: 10.1007/s10266-014-0190-1. Epub 2014 Dec 19.
PMID: 25523604DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kanyawat Rattanasuwan
Department of Oral Medicine, Mahidol University
- STUDY CHAIR
Kanyawat Rattanasuwan
Maha Chakri Sirindhorn Dental Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 10, 2009
First Posted
June 11, 2009
Study Start
February 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
October 13, 2010
Record last verified: 2010-10