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

NCT ID: NCT00918060

Last Updated: 2010-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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gel a

Group Type EXPERIMENTAL

Camella sinensis gel

Intervention Type DRUG

clinical effect of locally-delivered gel between Camella sinensis and placebo

gel b

Group Type PLACEBO_COMPARATOR

Camella sinensis gel

Intervention Type DRUG

clinical effect of locally-delivered gel between Camella sinensis and placebo

Interventions

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Camella sinensis gel

clinical effect of locally-delivered gel between Camella sinensis and placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

34 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Department of Oral Medicine, Mahidol University

Principal Investigators

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Kanyawat Rattanasuwan

Role: STUDY_DIRECTOR

Department of Oral Medicine, Mahidol University

Kanyawat Rattanasuwan

Role: STUDY_CHAIR

Maha Chakri Sirindhorn Dental Hospital

References

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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.

Reference Type DERIVED
PMID: 25523604 (View on PubMed)

Other Identifiers

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COA. No. MU-IRB 2008/153.0511

Identifier Type: -

Identifier Source: org_study_id