"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
About this trial
This is an interventional treatment trial for Gingivitis focused on measuring Gingivitis, Herbal medicine, Plaque control
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
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
NCT ID
NCT01898000
First Posted
July 3, 2013
Last Updated
July 10, 2013
Sponsor
Government Dental College and Research Institute, Bangalore
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
Learn more about this trial
"Triphala" - A New Herbal Mouthwash in Gingivitis
We'll reach out to this number within 24 hrs