NCT07426393

Brief Summary

Gingivitis is one of the commonly prevalent oral diseases worldwide which is caused by the bacterial biofilm adhering to the teeth surfaces. Chlorhexidine is the antimicrobial agent most familiar to dental professionals. The need for frequent application of Chlorhexidine and other side effects such as unpleasant taste and staining has stimulated the search for alternatives. "Triphala" is among the most common formulas used in Traditional Ayurvedic Medicine. Triphala has an antibacterial effect. In this context, a study was undertaken to ascertain the effects of a mouthwash prepared with Triphala on the oral health status and compare it with commercially available Chlorhexidine mouthwash.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
Last Updated

February 23, 2026

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

February 9, 2026

Last Update Submit

February 15, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • PIaque Index

    plaque index 0:no plaque is in the area adjacent to the gingiva plaque index 1:there is a plaque in the form of a thin film on the gingival margin plaque index 2:there is a visible plaque in the gingival pocket and gingival margin plaque index 3:there is a dense plaque in the gingival pocket and gingival margin

    30 days

  • Gingival Index

    Gingival index 0: Healthy gums. Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing. Gingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing. Gingival index 3: Red, oedematous and ulcerated gingiva. There is spontaneous bleeding.

    30 days

  • BIeeding Index

    30 days

Study Arms (2)

6% Triphala mouthwash

EXPERIMENTAL

Experimental: 15ml of 6%Triphala mouthwash twice daily for 30 days.

Other: 6% Triphala mouthwash

placebo Comparator:Placebo Participants received 15 ml of 6% chlorhexidine mouthwash

PLACEBO COMPARATOR

placebo Participants received 15 ml mouthwash twice daily for 30 days

Other: .2% chlorhexidine mouthwash

Interventions

participants received 15 ml of .2% chlorhexidine mouthwash twice daily for 30 days

placebo Comparator:Placebo Participants received 15 ml of 6% chlorhexidine mouthwash

participants received 15 ml of 6% triphala mouthwash twice daily for 30 days

6% Triphala mouthwash

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age groups of 18-45 years with
  • Mild to moderate gingivitis,
  • Patients with a minimum of 20 teeth, and
  • Patients who have not undergone periodontal treatment in the past 6 months.

You may not qualify if:

  • Use of anti-inflammatory drugs and antibiotics in previous 6 months;
  • Individuals with prosthetic appliances or orthodontic appliances that would interfere with evaluation
  • Allergy to Triphala and Chlorhexidine used in the study;
  • Smokers or users of tobacco in any form
  • Lactating females or pregnant women
  • Mental-retarded patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangladesh Medical University

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 220 individuals with chronic generalized gingivitis were recruited from the Outpatient Department of BMU, Dhaka. The current study was designed as a randomized control trial. * Group A: n = 110 was given Triphala mouthwash * Group B: n = 110 was given Chlorhexidine mouthwash
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 23, 2026

Study Start

March 15, 2025

Primary Completion

August 31, 2025

Study Completion

November 30, 2025

Last Updated

February 23, 2026

Record last verified: 2024-07

Locations