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"Triphala" - A New Herbal Mouthwash in Gingivitis

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Triphala mouthwash
Chlorhexidine mouthwash
Sponsored by
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring Gingivitis, Herbal medicine, Plaque control

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • systemically healthy subjects of 25-40 years of age with previously untreated gingivitis and minimum 20 teeth,
  • gingival index > 1,
  • pocket probing depth < 3 mm,
  • clinical attachment loss = 0,
  • with no evidence of radiographic bone loss

Exclusion Criteria:

  • use of systemic antibiotics and anti-inflammatory drugs in the previous 6 months,
  • known systemic disease,
  • with orthodontic appliances or bridge work that would interfere with evaluation,
  • allergy to ingredient used in the study,
  • alcoholics,
  • who use tobacco in any form,
  • mentally retarded subjects,
  • pregnant or
  • lactating females and
  • subjects with poor compliance

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in Gingival Index (GI)
    The primary outcome variable was the differences for the mean gingival Index (GI) from B/L to 7 days, 30 and 60 days.

    Secondary Outcome Measures

    Change in Plaque Index (PI)
    Differences in mean reduction in plaque index (PI) from baseline (B/L) to 7, 30 and 60 days

    Full Information

    First Posted
    July 3, 2013
    Last Updated
    July 10, 2013
    Sponsor
    Government Dental College and Research Institute, Bangalore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01898000
    Brief Title
    "Triphala" - A New Herbal Mouthwash in Gingivitis
    Official Title
    "Triphala" - A New Herbal Mouthwash in Gingivitis: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Government Dental College and Research Institute, Bangalore

    4. Oversight

    5. Study Description

    Brief Summary
    The present study was a randomized control clinical trial, which included 90 subjects with chronic generalised gingivitis of age group 25-40 years, reporting to outpatient department of Periodontics, Government Dental College & Research Institute, Bangalore form January 2013 to April 2013. The research protocol was initially submitted and approved by the Institutional Ethical Committee and Review Board of the Government Dental College and Research Institute, Bangalore. After ethical approval, all subjects were verbally informed and written signed informed consent was taken for participation in the study. Ninety subjects diagnosed with chronic generalized gingivitis were randomly assigned into three groups: Group I: Placebo mouthwash, Group II: Triphala (TRP) mouthwash, Group III: Chlorhexidine (CHX) mouthwash. Subjects were instructed to use mouth wash twice daily. The plaque index (PI), gingival index (GI) and oral hygiene index- simplified (OHI-S) and microbiological colony counts were recorded on baseline (B/L) and 7, 30 and 60 days respectively. TRP mouthwash was found to decrease the inflammatory parameters. As improvement in gingivitis was comparable to that of CHX mouthwash thus TRP mouthwash can be considered as a potential therapeutic agent in treatment of gingivitis.
    Detailed Description
    Objective: The aim of the present study is to evaluate the efficacy of triphala (TRP) as a mouthwash in reduction of plaque and gingivitis. Material & Methods: Ninety subjects diagnosed with chronic generalized gingivitis were randomly assigned into three groups: Group I: Placebo mouthwash, Group II: TRP mouthwash, Group III: Chlorhexidine (CHX) mouthwash. Subjects were instructed to use mouth wash twice daily. The plaque index (PI), gingival index (GI) and oral hygiene index- simplified (OHI-S) and microbiological colony counts were recorded on baseline (B/L) and 7, 30 and 60 days respectively. Results: There was a gradual decrease in the PI, GI and OHI-S scores by the 7 days, 30 days and 60 days time interval, respectively, in all three groups. Microbial counts also showed significant reduction in all the groups at all the time intervals except in Group 1. There was a significant difference with respect to reduction in PI, GI, OHI-S and microbiological counts in Group I as compared to Group II and Group III. However, no significant difference was found between Group II and Group III for all the parameters at all-time intervals. Conclusion: TRP mouthwash was found to decrease the inflammatory parameters. As improvement in gingivitis was comparable to that of CHX mouthwash thus TRP mouthwash can be considered as a potential therapeutic agent in treatment of gingivitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingivitis
    Keywords
    Gingivitis, Herbal medicine, Plaque control

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Triphala mouthwash
    Intervention Description
    Subjects were instructed to use 15ml mouthwash twice daily and were instructed not to rinse/eat anything for 30 min after mouthwash use. Subjects were also asked to refrain from all other unassigned forms of oral hygiene aids, including dental floss and chewing gum during the study. No oral hygiene instructions like brushing and flossing were given to the subjects to exclude the influence of improved oral hygiene practices on the results.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Chlorhexidine mouthwash
    Intervention Description
    Subjects were instructed to use 15ml mouthwash twice daily and were instructed not to rinse/eat anything for 30 min after mouthwash use. Subjects were also asked to refrain from all other unassigned forms of oral hygiene aids, including dental floss and chewing gum during the study. No oral hygiene instructions like brushing and flossing were given to the subjects to exclude the influence of improved oral hygiene practices on the results.
    Primary Outcome Measure Information:
    Title
    Change in Gingival Index (GI)
    Description
    The primary outcome variable was the differences for the mean gingival Index (GI) from B/L to 7 days, 30 and 60 days.
    Time Frame
    differences for the mean GI from B/L to 7 days, 30 and 60 days
    Secondary Outcome Measure Information:
    Title
    Change in Plaque Index (PI)
    Description
    Differences in mean reduction in plaque index (PI) from baseline (B/L) to 7, 30 and 60 days
    Time Frame
    From Baseline (B/L) to 7 days, 30 and 60 days
    Other Pre-specified Outcome Measures:
    Title
    Change in oral hygiene index simplified (OHI-S)
    Description
    differences in mean reduction in Oral hygiene index simplified ( OHI-S)from baseline (B/L) to 7 days, 30 days and 60 days
    Time Frame
    From baseline (B/L) to 7 days, 30 days and 60 days
    Title
    Change in microbiological colony counts
    Description
    in microbiological colony counts from baseline (B/L) to 7 days, 30 days and 60 days
    Time Frame
    From baseline (B/L) to 7 days, 30 days and 60 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: systemically healthy subjects of 25-40 years of age with previously untreated gingivitis and minimum 20 teeth, gingival index > 1, pocket probing depth < 3 mm, clinical attachment loss = 0, with no evidence of radiographic bone loss Exclusion Criteria: use of systemic antibiotics and anti-inflammatory drugs in the previous 6 months, known systemic disease, with orthodontic appliances or bridge work that would interfere with evaluation, allergy to ingredient used in the study, alcoholics, who use tobacco in any form, mentally retarded subjects, pregnant or lactating females and subjects with poor compliance

    12. IPD Sharing Statement

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    "Triphala" - A New Herbal Mouthwash in Gingivitis

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