Clinical Research Directory

Clinical Outcomes of Different Mouth Rinses During Clear Aligner Orthodontic Therapy

Sponsor: Manav Rachna International Institute of Research and Studies

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. 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.

Official title: Feasibility and Preliminary Clinical Outcomes of Alum, Triphala, and Chlorhexidine Mouth Rinses During Clear Aligner Therapy: A Pilot Randomized Controlled Trial

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