GingivitisNCT07426393
Comparisons of Efficacy of Triphala and Chlorhexidine Mouthwash Against Plaque Accumulation and Gingivitis.
A study testing 6% Triphala mouthwash and .2% chlorhexidine mouthwash in people with Gingivitis, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- 6% Triphala mouthwash and .2% chlorhexidine mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 Mar 2025to 30 Nov 2025
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparisons of Efficacy of Triphala and Chlorhexidine Mouthwash Against Plaque Accumulation and Gingivitis. A Randomized Controlled Trail.
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.
Read the detailed description
Dental plaque is the main cause of gingivitis and effective plaque control is essential for maintaining gingival health. Along with mechanical cleaning methods, mouthwashes are commonly used as adjunct therapy to reduce plaque accumulation and gingival inflammation. Chlorhexidine is considered the gold standard chemical plaque control agent but its long-term use is limited by side effects such as tooth staining and taste alteration. Triphala, a herbal formulation with known antimicrobial and anti-inflammatory properties has emerged as a potential alternative. Comparing the efficacy of triphala and chlorhexidine mouthwash against plaque accumulation and gingivitis may help to identify a safer and acceptable option for maintaining routine oral hygiene.
Aims and objectives:
To compare the efficacy of triphala and chlorhexidine mouth wash against plaque accumulation and gingivitis.
Materials and methods:
A randomized controlled trial was conducted among 220 patients with chronic generalized gingivitis attending the Outpatient Department of Bangladesh medical University (BMU), Dhaka. Participants were randomly assigned using shuffled numbered cards to Group A (Triphala mouthwash, n = 110) and Group B (Chlorhexidine mouthwash, n = 110).
- Conditions
- Gingivitis
- Being tested
- 6% Triphala mouthwash, .2% chlorhexidine mouthwash
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6% Triphala mouthwashOther
participants received 15 ml of 6% triphala mouthwash twice daily for 30 days
.2% chlorhexidine mouthwashOther
participants received 15 ml of .2% chlorhexidine mouthwash twice daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| 6% Triphala mouthwash | Experimental | Experimental: 15ml of 6%Triphala mouthwash twice daily for 30 days. Receives: 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 Receives: Other: .2% chlorhexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 30 days
BIeeding Index
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start15 Mar 2025
- Primary completion31 Aug 2025
- Study completion30 Nov 2025
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
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilruba Sarmin, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426393
- Sponsor's protocol ID
- BSMMU/2024/6798
- Status last verified
- Jul 2024
- First submitted
- 9 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Efficacy of Triphala and Chlorhexidine Mouthwash Against Plaque Accumulation and Gingivitis. A Randomized Controlled Trail.
- ClinicalTrials.gov ID
- NCT07426393
- Acronym / sponsor ID
- BSMMU/2024/6798
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 23 Feb 2026 (actual)
- 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.
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.
Detailed description
Dental plaque is the main cause of gingivitis and effective plaque control is essential for maintaining gingival health. Along with mechanical cleaning methods, mouthwashes are commonly used as adjunct therapy to reduce plaque accumulation and gingival inflammation. Chlorhexidine is considered the gold standard chemical plaque control agent but its long-term use is limited by side effects such as tooth staining and taste alteration. Triphala, a herbal formulation with known antimicrobial and anti-inflammatory properties has emerged as a potential alternative. Comparing the efficacy of triphala and chlorhexidine mouthwash against plaque accumulation and gingivitis may help to identify a safer and acceptable option for maintaining routine oral hygiene.
Aims and objectives:
To compare the efficacy of triphala and chlorhexidine mouth wash against plaque accumulation and gingivitis.
Materials and methods:
A randomized controlled trial was conducted among 220 patients with chronic generalized gingivitis attending the Outpatient Department of Bangladesh medical University (BMU), Dhaka. Participants were randomly assigned using shuffled numbered cards to Group A (Triphala mouthwash, n = 110) and Group B (Chlorhexidine mouthwash, n = 110).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 6% Triphala mouthwash | Experimental | Other: 6% Triphala mouthwashExperimental: 15ml of 6%Triphala mouthwash twice daily for 30 days. |
| placebo Comparator:Placebo Participants received 15 ml of 6% chlorhexidine mouthwash | Placebo comparator | Other: .2% chlorhexidine mouthwashplacebo Participants received 15 ml mouthwash twice daily for 30 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| 6% Triphala mouthwashparticipants received 15 ml of 6% triphala mouthwash twice daily for 30 days | Other | 6% Triphala mouthwash |
| .2% chlorhexidine mouthwashparticipants received 15 ml of .2% chlorhexidine mouthwash twice daily for 30 days | Other | placebo Comparator:Placebo Participants received 15 ml of 6% chlorhexidine mouthwash |
Primary outcome
PIaque Index
Time frame: 30 days
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
Gingival Index
Time frame: 30 days
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.
BIeeding Index
Time frame: 30 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 23 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6% Triphala mouthwash and .2% chlorhexidine mouthwash in people with Gingivitis, run by Bangladesh Medical University at 1 site in Bangladesh.
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 4 inclusion and 6 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 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
PIaque Index (time frame: 30 days). The study lists 3 primary outcomes in all. 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 23 Feb 2026.