Clear Aligner Cleaning: Brushing, Chlorhexidine, and BlueM Effects on Oral Microbial Ecology and Periodontal Indices

Summary

This randomized crossover study will assess how three aligner-cleaning methods affect early supragingival oral microbial ecology and periodontal health in adults using clear aligners. Each participant will complete three (1-month) periods in a randomized sequence with (1-week) washouts between periods: 1. Mechanical toothbrushing with fluoride toothpaste (control), 2. Chlorhexidine (CHX) mouthwash, and 3. an oxygen-based cleanser (BlueM). Primary ecological outcomes focus on early dysbiosis indicators Fusobacterium nucleatum and Prevotella intermedia measured on retrieved aligner inner-surface biofilm and on supragingival plaque at the gingival margin. Secondary outcomes include periodontal indices (plaque index, gingival index, bleeding on probing) at index teeth and the host inflammatory marker MMP-8 in matrix-paired extracts (plaque and aligner). Study visits occur at baseline and at the end of each 1-month period. Supragingival plaque is collected from the upper and lower first molars and central incisors; used aligners are swabbed immediately after removal. Participants are instructed to wear aligners about 22 hours/day, change trays every 10 days, remove aligners for meals and oral hygiene, and drink only water while aligners are in. Laboratory procedures include blinded culture enumeration under coded labels (performed by a single trained operator, FA), confocal laser scanning microscopy, and RNA isolation with species-specific qRT-PCR; microscopy is conducted unblinded after decoding. The study will determine whether chlorhexidine or an oxygen-based cleanser produces more favorable early ecological changes and periodontal outcomes than mechanical brushing alone in clear aligner therapy.

Timeline

Start

2026-02

Primary completion

2026-10

Completion

2026-10

Publications

• Background Heller D, Helmerhorst EJ, Gower AC, Siqueira WL, Paster BJ, Oppenheim FG. Microbial Diversity in the Early In Vivo-Formed Dental Biofilm. Appl Environ Microbiol. 2016 Jan 8;82(6):1881-8. doi: 10.1128/AEM.03984-15.
• Background Zhao R, Huang R, Long H, Li Y, Gao M, Lai W. The dynamics of the oral microbiome and oral health among patients receiving clear aligner orthodontic treatment. Oral Dis. 2020 Mar;26(2):473-483. doi: 10.1111/odi.13175. Epub 2020 Jan 8.
• Background Miguel YD, Alcântara PR, Toyofuku ACMM, Shimizu RH. Periodontal monitoring in orthodontic treatment with orthodontic aligners: proof of concept. Rev Odontol UNESP. 2024;53:e20240016. doi:10.1590/1807-2577.01624

Drugs

Indications