Feasibility and Preliminary Clinical Outcomes of Alum, Triphala, and Chlorhexidine Mouth Rinses During Clear Aligner Therapy: A Pilot Randomized Controlled Trial
Sponsor study identifier
interventional
30
1 country
1
Study Start
December 10, 2024
Actual (reported)Primary Completion
December 15, 2025
Actual (reported)Study Completion
December 15, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 10, 2024
Actual (reported)December 15, 2025
Actual (reported)December 15, 2025
Actual (reported)September 24, 2026
Actual (reported)October 8, 2026
Actual (reported)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.
Baseline (T0) to 30 days (T2)
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.
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.
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
Faculty of Dental Sciences
Faridabad, Haryana, 121004, India
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.
Mehta 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.
30 participants (actual enrollment reported by the registry).
First Submitted
September 24, 2026
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.
0.2% chlorhexidine gluconate mouth rinse; 10 mL used twice daily for 30 days, with 60-second rinsing followed by expectoration.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Ahuja, 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
First Posted
October 8, 2026
Study Start
December 10, 2024
Actual (reported)Primary Completion
December 15, 2025
Actual (reported)Study Completion
December 15, 2025
Actual (reported)Last Updated
October 8, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: