"Triphala" - A New Herbal Mouthwash in Gingivitis

NCT01898000 | Completed

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2011-2012
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingivitis

Keywords

Gingivitis; Herbal medicine; Plaque control

Outcome Measures

Primary Outcomes (1)

• 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.

  differences for the mean GI from B/L to 7 days, 30 and 60 days

Secondary Outcomes (1)

• Change in Plaque Index (PI)

  From Baseline (B/L) to 7 days, 30 and 60 days

Other Outcomes (2)

• Change in oral hygiene index simplified (OHI-S)

  From baseline (B/L) to 7 days, 30 days and 60 days

• Change in microbiological colony counts

  From baseline (B/L) to 7 days, 30 days and 60 days

Interventions

Triphala mouthwash BEHAVIORAL

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 mouthwash BEHAVIORAL

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.

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 12, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 12, 2013

Record last verified: 2013-07