Patient Comfort Evaluation of Two Clear Aligner Edge Designs Comparing Supragingival and Juxtagingival Trimming Lines in Orthodontic Treatment Using a Split-Mouth Approach

What this Trial Is About

This research aims to compare patient comfort between two designs of clear aligner trimming lines used in orthodontic treatment. The study focuses on the supragingival design, which extends about 2 mm onto the marginal gingiva, and the juxtagingival design, which follows the gingival contour without covering it. These designs, made from the same tri-layer thermoplastic material, may affect oral comfort differently, but previous evidence has mainly compared aligners to fixed appliances rather than among aligner designs. Participants in active clear aligner treatment wear one trimming-line design on the upper dental arch and the other on the lower arch, serving as their own control. After at least four weeks of wearing both designs, participants complete a 20-item online questionnaire anonymously, rating the frequency of various oral sensations and experiences related to the aligner edges on each arch separately. The study compares responses for the two designs within each participant to evaluate differences in comfort. During the study, participants complete the questionnaire once after a minimum of four weeks of wear. The questionnaire covers aspects such as speech, mucosal sensation, retention, foreign-body feeling, salivation, and taste, with answers on a three-point scale. Researchers analyze item-level and total scores to assess differences in comfort between the two trimming-line designs. The trial is observational and monitors patient-reported outcomes without altering prescribed orthodontic care.

Comparison of Patient-Reported Comfort Between Two Clear Aligner Trimming-Line Designs: A Split-Mouth Study