NCT07660809 Comparison of Patient-Reported Comfort Between Two Clear Aligner Trimming-Line Designs: A Split-Mouth Study
| NCT ID | NCT07660809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures |
| Condition | Patient Comfort |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2026-07-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
EMILIA (PRODEA) RUSU
PRINCIPAL INVESTIGATOR
George Emil Palade University of Medicine, Pharmacy, Sciences, and Technology of Targu Mures, 38 Gheorghe Marinescu Street, 540139 Targu Mures, Romania
Frequently Asked Questions
Who can join the NCT07660809 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Patient Comfort. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07660809 currently recruiting?
Yes, NCT07660809 is actively recruiting participants. Contact the research team at rusu.emilia.24@stud.umfst.ro for enrollment information.
Where is the NCT07660809 trial being conducted?
This trial is being conducted at Sibiu, Romania.
Who is sponsoring the NCT07660809 clinical trial?
NCT07660809 is sponsored by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures. The principal investigator is EMILIA (PRODEA) RUSU at George Emil Palade University of Medicine, Pharmacy, Sciences, and Technology of Targu Mures, 38 Gheorghe Marinescu Street, 540139 Targu Mures, Romania. The trial plans to enroll 70 participants.