Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

"Triphala" - A New Herbal Mouthwash in Gingivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01898000
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : July 12, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

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.


Condition or disease Intervention/treatment Phase
Gingivitis Behavioral: Triphala mouthwash Behavioral: Chlorhexidine mouthwash Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Triphala" - A New Herbal Mouthwash in Gingivitis: A Randomized Controlled Clinical Trial
Study Start Date : January 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Triphala mouthwash
    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.
  • Behavioral: Chlorhexidine mouthwash
    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 Measures :
  1. Change in Gingival Index (GI) [ Time Frame: differences for the mean GI from B/L to 7 days, 30 and 60 days ]
    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 :
  1. Change in Plaque Index (PI) [ Time Frame: From Baseline (B/L) to 7 days, 30 and 60 days ]
    Differences in mean reduction in plaque index (PI) from baseline (B/L) to 7, 30 and 60 days


Other Outcome Measures:
  1. Change in oral hygiene index simplified (OHI-S) [ Time Frame: From baseline (B/L) to 7 days, 30 days and 60 days ]
    differences in mean reduction in Oral hygiene index simplified ( OHI-S)from baseline (B/L) to 7 days, 30 days and 60 days

  2. Change in microbiological colony counts [ Time Frame: From baseline (B/L) to 7 days, 30 days and 60 days ]
    in microbiological colony counts from baseline (B/L) to 7 days, 30 days and 60 days



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Layout table for additonal information
Responsible Party: Dr. A R Pradeep, Professor, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT01898000     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2011-2012
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: July 2013

Keywords provided by Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore:
Gingivitis
Herbal medicine
Plaque control

Additional relevant MeSH terms:
Layout table for MeSH terms
Chlorhexidine
Chlorhexidine gluconate
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents