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臨床試験

Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE

NCT: NCT07858370 · NOT_YET_RECRUITING

NCT識別子NCT07858370
ステータスNOT_YET_RECRUITING
開始日2026-11-01
完了2028-05-01
SponsorAdiyaman University (OTHER)
First posted
Last updated

概要

This prospective, controlled observational study aims to evaluate three-dimensional (3D) facial soft tissue changes following miniscrew-assisted rapid palatal expansion (MARPE) and determine whether these changes are clinically perceptible to orthodontic specialists and patients. A total of 55 postpubertal participants aged 16-25 years will be included: 40 patients undergoing MARPE as part of their routine orthodontic treatment and 15 control participants who will not undergo maxillary expansion. Treatment decisions will be made independently of study participation. Facial soft tissue changes will be assessed using 3D facial scans. The MARPE group will be scanned before expansion (T0), immediately after active expansion (T1), and three months after expansion (T2). The control group will undergo two facial scans at comparable baseline and follow-up intervals. Changes in facial regions, including the nose, paranasal area, midface, and upper lip, will be evaluated. Blinded orthodontic specialists will assess the clinical perceptibility of changes using standardized facial images, while participants will provide their own perception of facial changes through questionnaires. When available from routine clinical records, skeletal and dental expansion measurements will also be analyzed in relation to the observed soft tissue changes. The study aims to clarify the magnitude, distribution, and clinical relevance of facial soft tissue changes associated with MARPE.

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