RecruitingNCT07660809

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

Comparison of Patient-Reported Comfort Between Supragingival and Juxtagingival Clear Aligner Trimming-Line Designs: A Cross-Sectional, Within-Subject Split-Mouth Study


Sponsor

George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

Enrollment

70 participants

Start Date

Jul 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

* The trimming-line design of clear aligners (supragingival versus juxtagingival) is a routine clinical decision whose influence on patient-reported comfort has not been established; available evidence on aligner comfort derives almost exclusively from comparisons with fixed appliances. * This observational, cross-sectional study compares two clear aligner trimming-line designs with respect to patient-reported comfort: a supragingival design, whose edge rests on the marginal gingiva, and a juxtagingival design, whose edge follows the gingival contour without covering it. Because the two designs sit differently against the gingival soft tissue, they may be experienced differently during wear. * Participants are patients already wearing one trimming-line design on one dental arch and the other on the contralateral arch; each participant thus serves as their own control. After a minimum of four weeks of wear, participants complete a 20-item questionnaire once, rating the frequency of defined oral experiences for the maxillary and mandibular arch separately on a three-point ordinal scale (0 = none, 1 = occasional, 2 = frequent). * The questionnaire is anonymous; the design worn on each arch is identified from which of two identical forms a participant completes. Responses for the two designs are compared within each participant. The study evaluates whether trimming-line design is associated with differences in patient-reported comfort.


Eligibility

Min Age: 15 Years

Inclusion Criteria6

  • Adolescent or adult patient (aged 15 years or older)
  • Active orthodontic treatment with clear aligners, including finishing (refinement) aligners
  • Wearing two clear aligners with different trimming-line designs, one per dental arch: a supragingival design on one arch and a juxtagingival design on the contralateral arch
  • At least 4 weeks of wear of the two designs at the time of questionnaire completion
  • Good treatment compliance
  • Willing and able to complete the online questionnaire and provide the required consent

Exclusion Criteria3

  • Mixed orthodontic treatment (aligners combined with fixed appliances)
  • Pre-existing neurological, cognitive, or speech disorders
  • Systemic conditions affecting the oral cavity (e.g., xerostomia, mucosal disorders)

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Interventions

DEVICESupragingival trimming-line design

Clear aligner edge covering approximately 2 mm of marginal gingiva (straight cut), worn on one dental arch.

DEVICEJuxtagingival festooned trimming-line design

Clear aligner edge following the scalloped gingival contour, terminating at the free gingival margin without covering the gingiva, worn on the contralateral arch.


Locations(1)

Aorys Clinic

Sibiu, Sibiu County, Romania

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NCT07660809


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