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

Primary Purpose

Periodontitis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Camella sinensis gel
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

34 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    gel a

    gel b

    Arm Description

    Outcomes

    Primary Outcome Measures

    pocket depth reduction, clinical attachment level gain, gingival index, bleeding score

    Secondary Outcome Measures

    plaque index

    Full Information

    First Posted
    June 10, 2009
    Last Updated
    October 9, 2010
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00918060
    Brief Title
    Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts as an Adjunct in Peridontitis Treatment
    Official Title
    Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    December 2010 (Anticipated)
    Study Completion Date
    December 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mahidol University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    gel a
    Arm Type
    Experimental
    Arm Title
    gel b
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Camella sinensis gel
    Intervention Description
    clinical effect of locally-delivered gel between Camella sinensis and placebo
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    plaque index
    Time Frame
    baseline, 1, 3, and 6 month after gel had loaded

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    34 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kanyawat Rattanasuwan
    Organizational Affiliation
    Department of Oral Medicine, Mahidol University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Kanyawat Rattanasuwan
    Organizational Affiliation
    Maha Chakri Sirindhorn Dental Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25523604
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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