An interventional study of Alum Mouth Rinse and Triphala-based Herbal Mouth Rinse in Plaque-Induced Gingivitis and Orthodontic Treatment, sponsored by Manav Rachna International Institute of Research and Studies. Completed at 1 site in India. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Manav Rachna International Institute of Research and Studies · Not applicable, Interventional, and Treatment
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.
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.
609 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's enrollment of 30 is below the median of 63 across 494 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Manav Rachna International Institute of Research and Studies is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Drug: Alum Mouth Rinse
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.
Drug: Triphala-based Herbal Mouth Rinse
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.
Drug: Chlorhexidine mouth rinse
Drug pages: Aluminum sulfate · Aluminium sulfate
0.02 M potassium aluminum sulfate solution; 10 mL used twice daily for 30 days, with 60-second rinsing followed by expectoration.
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
0.2% chlorhexidine gluconate mouth rinse; 10 mL used twice daily for 30 days, with 60-second rinsing followed by expectoration.
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.
Time frame: Baseline (T0) to 30 days (T2)
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Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Aluminum sulfate · Aluminium sulfate
Manav Rachna International Institute of Research and Studies