GingivitisNCT01898000
"Triphala" - A New Herbal Mouthwash in Gingivitis
A study testing Triphala mouthwash and Chlorhexidine mouthwash in people with Gingivitis, run by Government Dental College and Research Institute, Bangalore.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Triphala mouthwash and Chlorhexidine mouthwash
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 10Show fewer
- mentally retarded subjects,
- pregnant or
- lactating females and
- subjects with poor compliance
About this study
Official title: "Triphala" - A New Herbal Mouthwash in Gingivitis: A Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Gingivitis
- Being tested
- Triphala mouthwash, Chlorhexidine mouthwash
- Keywords
- Gingivitis, Herbal medicine, Plaque control
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triphala mouthwashBehavioural
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.
Chlorhexidine mouthwashBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: differences for the mean GI from B/L to 7 days, 30 and 60 days
Secondary outcomes (1)
Change in Plaque Index (PI)
Differences in mean reduction in plaque index (PI) from baseline (B/L) to 7, 30 and 60 days
Measured: From Baseline (B/L) to 7 days, 30 and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Dental College and Research Institute, Bangalore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898000
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/2/2011-2012
- Status last verified
- Jul 2013
- First submitted
- 3 Jul 2013
- Last updated
- 12 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Triphala" - A New Herbal Mouthwash in Gingivitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01898000
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/2/2011-2012
- Conditions
- Gingivitis
- Keywords
- Gingivitis, Herbal medicine, Plaque control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triphala mouthwashSubjects 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. | Behavioural | – |
| Chlorhexidine mouthwashSubjects 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. | Behavioural | – |
Primary outcome
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.
1 secondary outcome
Change in Plaque Index (PI)
Time frame: From Baseline (B/L) to 7 days, 30 and 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Triphala mouthwash and Chlorhexidine mouthwash in people with Gingivitis, run by Government Dental College and Research Institute, Bangalore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gingival Index (GI) (time frame: differences for the mean GI from B/L to 7 days, 30 and 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2013.