Plaque-Induced GingivitisNCT07865416
Clinical Outcomes of Different Mouth Rinses During Clear Aligner Orthodontic Therapy
A study testing Alum Mouth Rinse, Triphala-based Herbal Mouth Rinse and Chlorhexidine mouth rinse in people with Plaque-Induced Gingivitis and Orthodontic Treatment, run by Manav Rachna International Institute of Research and Studies at 1 site in India.
Trial summary
This pilot randomized controlled clinical trial will evaluate the feasibility and preliminary clinical effects of three mouth rinses-alum, Triphala-based herbal mouth rinse, and 0.2% chlorhexidine-in adults undergoing clear aligner orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Plaque-Induced Gingivitis, Orthodontic Treatment
- What is being tested?
- Alum Mouth Rinse, Triphala-based Herbal Mouth Rinse and Chlorhexidine mouth rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 10 Dec 2024to 15 Dec 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-35 years.
- Currently undergoing active clear aligner orthodontic treatment.
- Clear aligner use for at least 4 weeks before enrolment.
- Wearing clear aligners for approximately 20-22 hours per day.
- Presence of mild to moderate plaque-induced gingivitis, defined as a Löe and Silness Gingival Index score of 1-2.
- Presence of at least 20 natural teeth.
- Willingness to comply with the study protocol and study instructions.
- Ability and willingness to provide written informed consent.
Who cannot join
- Use of systemic antibiotics within the previous 3 months.
- Use of antimicrobial mouth rinses within the previous 1 month.
- History of periodontal pockets greater than 3 mm.
- Systemic diseases that may affect periodontal health.
- Current smoking or tobacco use.
- Pregnancy or lactation.
- Known allergy or hypersensitivity to any component of the study mouth rinses.
- Current use of systemic medications that may affect salivary flow or gingival status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Preliminary Clinical Outcomes of Alum, Triphala, and Chlorhexidine Mouth Rinses During Clear Aligner Therapy: A Pilot Randomized Controlled Trial
This pilot randomized controlled clinical trial will evaluate the feasibility and preliminary clinical effects of three mouth rinses-alum, Triphala-based herbal mouth rinse, and 0.2% chlorhexidine-in adults undergoing clear aligner orthodontic treatment.
Clear aligners and bonded attachments may contribute to plaque accumulation and gingival inflammation. Mouth rinses may provide an additional measure for controlling plaque and gingival inflammation during orthodontic treatment. Chlorhexidine is a commonly used antimicrobial mouth rinse, while alum and Triphala are being evaluated as alternative agents.
Read more
A total of 30 adults aged 18-35 years undergoing active clear aligner therapy and presenting with mild to moderate plaque-induced gingivitis will be randomly assigned in equal numbers to one of three groups. Participants will use their assigned mouth rinse twice daily for 30 days.
Gingival inflammation will be assessed using the Gingival Index, and plaque accumulation will be assessed using the Plaque Index at baseline, 15 days, and 30 days. Salivary Streptococcus mutans levels will also be assessed. Compliance with mouth-rinse use and other feasibility measures, including recruitment and retention, will be recorded.
The study is intended as a pilot trial to assess feasibility, estimate variability and preliminary treatment effects, and provide information for the design of a future adequately powered clinical trial.
Read the detailed description
This is a pilot, randomized, parallel-group, three-arm controlled clinical trial designed to evaluate the preliminary clinical effects and feasibility of three mouth rinses in adults undergoing active clear aligner orthodontic therapy.
Participants will be recruited from the Department of Orthodontics and Dentofacial Orthopaedics, Manav Rachna Dental College, Manav Rachna International Institute of Research and Studies (MRIIRS), Faridabad, India. Eligible participants will be adults aged 18-35 years undergoing active clear aligner therapy, with at least 20 natural teeth and mild to moderate plaque-induced gingivitis. Participants must be willing to comply with the study procedures and provide written informed consent.
A total of 30 participants will be allocated in a 1:1:1 ratio to three intervention groups using computer-generated block randomization with a block size of three. Allocation will be concealed using sequentially numbered opaque sealed envelopes prepared by an independent investigator.
The three intervention groups will receive either 0.02 M potassium aluminum sulfate (alum) mouth rinse, a Triphala-based herbal mouth rinse, or 0.2% chlorhexidine gluconate mouth rinse. Participants will use 10 mL of the assigned mouth rinse twice daily for 30 days and will be instructed to rinse for 60 seconds before expectorating. Participants will continue their usual toothbrushing practices and maintain their prescribed clear aligner wear.
Clinical assessments will be performed at baseline, 15 days, and 30 days. The primary clinical outcome is change in Gingival Index from baseline to 30 days. Secondary outcomes include changes in Plaque Index and salivary Streptococcus mutans counts, together with feasibility measures such as recruitment, retention, and adherence to the mouth-rinse regimen.
Plaque and gingival inflammation will be assessed using standardized clinical indices. Salivary Streptococcus mutans levels will be evaluated using a culture-based method, with results expressed as log10 colony-forming units per millilitre. Compliance will be assessed using participant rinse logs and measurement of returned bottle weight.
Participants will not be blinded because of the differences in taste and sensory characteristics of the mouth rinses. Clinical outcome assessors and laboratory personnel will be blinded to treatment allocation. Statistical analysis will also be performed using blinded group assignments.
The study is intended primarily to assess feasibility and generate preliminary estimates of outcome variability and treatment effects rather than provide definitive evidence of comparative efficacy. These estimates may inform the design and sample-size planning of a future adequately powered randomized controlled trial.
- Conditions
- Plaque-Induced Gingivitis, Orthodontic Treatment
- Being tested
- Alum Mouth Rinse, Triphala-based Herbal Mouth Rinse, Chlorhexidine mouth rinse
- Keywords
- Clear aligners, Gingival inflammation, Orthodontic treatment, Plaque-induced gingivitis, Mouth rinse, Streptococcus mutans
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alum Mouth RinseDrug
0.02 M potassium aluminum sulfate solution; 10 mL used twice daily for 30 days, with 60-second rinsing followed by expectoration.
Triphala-based Herbal Mouth RinseDrug
Commercial Triphala-based herbal mouth rinse containing Terminalia chebula, Terminalia bellirica, and Emblica officinalis extracts; 10 mL used twice daily for 30 days, with 60-second rinsing followed by expectoration
Chlorhexidine mouth rinseDrug
0.2% chlorhexidine gluconate mouth rinse; 10 mL used twice daily for 30 days, with 60-second rinsing followed by expectoration.
| Study group | Role | What they receive |
|---|---|---|
| Alum Mouth Rinse | Experimental | Participants allocated to this arm will use a 0.02 M potassium aluminum sulfate (alum) mouth rinse. Participants will use 10 mL of the assigned mouth rinse twice daily, in the morning and evening after brushing, for 30 days. The mouth rinse will be swished for 60 seconds and then expectorated. Participants will continue their routine oral hygiene practices and prescribed clear aligner wear throughout the study. Receives: Drug: Alum Mouth Rinse |
| Triphala-based Herbal Mouth Rinse | Experimental | Participants allocated to this arm will use a commercially available Triphala-based herbal mouth rinse containing extracts of Terminalia chebula, Terminalia bellirica, and Emblica officinalis. Participants will use 10 mL of the assigned mouth rinse twice daily for 30 days. The mouth rinse will be swished for 60 seconds and then expectorated. Participants will continue their routine oral hygiene practices and prescribed clear aligner wear throughout the study. Receives: Drug: Triphala-based Herbal Mouth Rinse |
| Chlorhexidine Mouth Rinse | Active comparator | Participants allocated to this arm will use a 0.2% chlorhexidine gluconate mouth rinse. Participants will use 10 mL of the assigned mouth rinse twice daily, in the morning and evening after brushing, for 30 days. The mouth rinse will be swished for 60 seconds and then expectorated. Participants will continue their routine oral hygiene practices and prescribed clear aligner wear throughout the study. Receives: Drug: Chlorhexidine mouth rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plaque Index(PI) and Gingival Index (GI)
Change in Gingival Index (Löe and Silness) from baseline (T0) to 30 days (T2). Gingival inflammation will be assessed using the Löe and Silness Gingival Index on the specified index teeth by a calibrated outcome assessor blinded to intervention allocation.
Measured: Baseline (T0) to 30 days (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start10 Dec 2024
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Plaque-Induced 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
- This is a pilot, three-arm, parallel-group randomized controlled clinical trial. Participants will be randomly allocated in a 1:1:1 ratio to receive alum, Triphala-based herbal, or 0.2% chlorhexidine mouth rinse for 30 days. Clinical and microbiological outcomes will be assessed at baseline, 15 days, and 30 days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manav Rachna International Institute of Research and Studies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865416
- Sponsor's protocol ID
- ManavRachnaIIRS
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olmez A, Can H, Ayhan H, Okur H. Effect of an alum-containing mouthrinse in children for plaque and salivary levels of selected oral microflora. J Clin Pediatr Dent. 1998 Summer;22(4):335-40.
PubMed 9796505Mehta V, Mathur A, Tripathy S, Sa R, Sharma T. Effectiveness of herbal oral care products in reducing dental plaque and gingivitis: an overview of systematic reviews. Can J Dent Hyg. 2024 Jun 1;58(2):120-134. eCollection 2024 Jun.
PubMed 38974822Ahuja, D., Shetty, P., Giri, S., Mohammed, A., Kamath, V., Ravi, M. S. et al. Analysis of Streptococcus mutans level with the use of different mouth rinses during orthodontic treatment. J. Pharm. Negat. Results 13, 1967-1971 (2022).
Singaraju, A., Nuvvula, S., Rudravaram, V. R. K., Anchala, K., Venkata Saikiran, K. & Mallineni, S. K. Efficacy of Triphala and chlorhexidine mouthwashes on gingival inflammation and dental plaque in children: a systematic review. Oral 4, 567-577 (2024). https://doi.org/10.3390/oral4040044
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Clinical Outcomes of Alum, Triphala, and Chlorhexidine Mouth Rinses During Clear Aligner Therapy: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07865416
- Acronym / sponsor ID
- ManavRachnaIIRS
- Conditions
- Plaque-Induced Gingivitis, Orthodontic Treatment
- Keywords
- Clear aligners, Gingival inflammation, Orthodontic treatment, Plaque-induced gingivitis, Mouth rinse, Streptococcus mutans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Manav Rachna International Institute of Research and StudiesUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 8 Oct 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.
This pilot randomized controlled clinical trial will evaluate the feasibility and preliminary clinical effects of three mouth rinses-alum, Triphala-based herbal mouth rinse, and 0.2% chlorhexidine-in adults undergoing clear aligner orthodontic treatment.
Clear aligners and bonded attachments may contribute to plaque accumulation and gingival inflammation. Mouth rinses may provide an additional measure for controlling plaque and gingival inflammation during orthodontic treatment. Chlorhexidine is a commonly used antimicrobial mouth rinse, while alum and Triphala are being evaluated as alternative agents.
A total of 30 adults aged 18-35 years undergoing active clear aligner therapy and presenting with mild to moderate plaque-induced gingivitis will be randomly assigned in equal numbers to one of three groups. Participants will use their assigned mouth rinse twice daily for 30 days.
Gingival inflammation will be assessed using the Gingival Index, and plaque accumulation will be assessed using the Plaque Index at baseline, 15 days, and 30 days. Salivary Streptococcus mutans levels will also be assessed. Compliance with mouth-rinse use and other feasibility measures, including recruitment and retention, will be recorded.
The study is intended as a pilot trial to assess feasibility, estimate variability and preliminary treatment effects, and provide information for the design of a future adequately powered clinical trial.
Detailed description
This is a pilot, randomized, parallel-group, three-arm controlled clinical trial designed to evaluate the preliminary clinical effects and feasibility of three mouth rinses in adults undergoing active clear aligner orthodontic therapy.
Participants will be recruited from the Department of Orthodontics and Dentofacial Orthopaedics, Manav Rachna Dental College, Manav Rachna International Institute of Research and Studies (MRIIRS), Faridabad, India. Eligible participants will be adults aged 18-35 years undergoing active clear aligner therapy, with at least 20 natural teeth and mild to moderate plaque-induced gingivitis. Participants must be willing to comply with the study procedures and provide written informed consent.
A total of 30 participants will be allocated in a 1:1:1 ratio to three intervention groups using computer-generated block randomization with a block size of three. Allocation will be concealed using sequentially numbered opaque sealed envelopes prepared by an independent investigator.
The three intervention groups will receive either 0.02 M potassium aluminum sulfate (alum) mouth rinse, a Triphala-based herbal mouth rinse, or 0.2% chlorhexidine gluconate mouth rinse. Participants will use 10 mL of the assigned mouth rinse twice daily for 30 days and will be instructed to rinse for 60 seconds before expectorating. Participants will continue their usual toothbrushing practices and maintain their prescribed clear aligner wear.
Clinical assessments will be performed at baseline, 15 days, and 30 days. The primary clinical outcome is change in Gingival Index from baseline to 30 days. Secondary outcomes include changes in Plaque Index and salivary Streptococcus mutans counts, together with feasibility measures such as recruitment, retention, and adherence to the mouth-rinse regimen.
Plaque and gingival inflammation will be assessed using standardized clinical indices. Salivary Streptococcus mutans levels will be evaluated using a culture-based method, with results expressed as log10 colony-forming units per millilitre. Compliance will be assessed using participant rinse logs and measurement of returned bottle weight.
Participants will not be blinded because of the differences in taste and sensory characteristics of the mouth rinses. Clinical outcome assessors and laboratory personnel will be blinded to treatment allocation. Statistical analysis will also be performed using blinded group assignments.
The study is intended primarily to assess feasibility and generate preliminary estimates of outcome variability and treatment effects rather than provide definitive evidence of comparative efficacy. These estimates may inform the design and sample-size planning of a future adequately powered randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a pilot, three-arm, parallel-group randomized controlled clinical trial. Participants will be randomly allocated in a 1:1:1 ratio to receive alum, Triphala-based herbal, or 0.2% chlorhexidine mouth rinse for 30 days. Clinical and microbiological outcomes will be assessed at baseline, 15 days, and 30 days.
| Arm | Type | Receives |
|---|---|---|
| Alum Mouth Rinse | Experimental | Drug: Alum Mouth RinseParticipants allocated to this arm will use a 0.02 M potassium aluminum sulfate (alum) mouth rinse. Participants will use 10 mL of the assigned mouth rinse twice daily, in the morning and evening after brushing, for 30 days. The mouth rinse will be swished for 60 seconds and then expectorated. Participants will continue their routine oral hygiene practices and prescribed clear aligner wear throughout the study. |
| Triphala-based Herbal Mouth Rinse | Experimental | Drug: Triphala-based Herbal Mouth RinseParticipants allocated to this arm will use a commercially available Triphala-based herbal mouth rinse containing extracts of Terminalia chebula, Terminalia bellirica, and Emblica officinalis. Participants will use 10 mL of the assigned mouth rinse twice daily for 30 days. The mouth rinse will be swished for 60 seconds and then expectorated. Participants will continue their routine oral hygiene practices and prescribed clear aligner wear throughout the study. |
| Chlorhexidine Mouth Rinse | Active comparator | Drug: Chlorhexidine mouth rinseParticipants allocated to this arm will use a 0.2% chlorhexidine gluconate mouth rinse. Participants will use 10 mL of the assigned mouth rinse twice daily, in the morning and evening after brushing, for 30 days. The mouth rinse will be swished for 60 seconds and then expectorated. Participants will continue their routine oral hygiene practices and prescribed clear aligner wear throughout the study. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults aged 18-35 years.
- Currently undergoing active clear aligner orthodontic treatment.
- Clear aligner use for at least 4 weeks before enrolment.
- Wearing clear aligners for approximately 20-22 hours per day.
- Presence of mild to moderate plaque-induced gingivitis, defined as a Löe and Silness Gingival Index score of 1-2.
Key exclusion criteria (8 listed)
- Use of systemic antibiotics within the previous 3 months.
- Use of antimicrobial mouth rinses within the previous 1 month.
- History of periodontal pockets greater than 3 mm.
- Systemic diseases that may affect periodontal health.
- Current smoking or tobacco use.
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 |
|---|---|---|
| Alum Mouth Rinse0.02 M potassium aluminum sulfate solution; 10 mL used twice daily for 30 days, with 60-second rinsing followed by expectoration. | Drug | Alum Mouth Rinse |
| Triphala-based Herbal Mouth RinseCommercial Triphala-based herbal mouth rinse containing Terminalia chebula, Terminalia bellirica, and Emblica officinalis extracts; 10 mL used twice daily for 30 days, with 60-second rinsing followed by expectoration | Drug | Triphala-based Herbal Mouth Rinse |
| Chlorhexidine mouth rinse0.2% chlorhexidine gluconate mouth rinse; 10 mL used twice daily for 30 days, with 60-second rinsing followed by expectoration. | Drug | Chlorhexidine Mouth Rinse |
Primary outcome
Change in Plaque Index(PI) and Gingival Index (GI)
Time frame: Baseline (T0) to 30 days (T2)
Change in Gingival Index (Löe and Silness) from baseline (T0) to 30 days (T2). Gingival inflammation will be assessed using the Löe and Silness Gingival Index on the specified index teeth by a calibrated outcome assessor blinded to intervention allocation.
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 8 Oct 2026.
- Background: PubMed 9796505Olmez A, Can H, Ayhan H, Okur H. Effect of an alum-containing mouthrinse in children for plaque and salivary levels of selected oral microflora. J Clin Pediatr Dent. 1998 Summer;22(4):335-40.
- Background: PubMed 38974822Mehta V, Mathur A, Tripathy S, Sa R, Sharma T. Effectiveness of herbal oral care products in reducing dental plaque and gingivitis: an overview of systematic reviews. Can J Dent Hyg. 2024 Jun 1;58(2):120-134. eCollection 2024 Jun.
- Results publicationAhuja, D., Shetty, P., Giri, S., Mohammed, A., Kamath, V., Ravi, M. S. et al. Analysis of Streptococcus mutans level with the use of different mouth rinses during orthodontic treatment. J. Pharm. Negat. Results 13, 1967-1971 (2022).
- Results publicationSingaraju, A., Nuvvula, S., Rudravaram, V. R. K., Anchala, K., Venkata Saikiran, K. & Mallineni, S. K. Efficacy of Triphala and chlorhexidine mouthwashes on gingival inflammation and dental plaque in children: a systematic review. Oral 4, 567-577 (2024). https://doi.org/10.3390/oral4040044
- Individual participant dataSharing planned: No
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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 Alum Mouth Rinse, Triphala-based Herbal Mouth Rinse and Chlorhexidine mouth rinse in people with Plaque-Induced Gingivitis and Orthodontic Treatment, run by Manav Rachna International Institute of Research and Studies at 1 site in India.
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 8 inclusion and 8 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 8 Oct 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 India. 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. 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 Plaque Index(PI) and Gingival Index (GI) (time frame: Baseline (T0) to 30 days (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07865416, which also lists 4 linked publications.
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 8 Oct 2026.