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NCT07858370

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

Sponsor: Adiyaman University

View on ClinicalTrials.gov

Summary

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.

Official title: Evaluation of Three-Dimensional Facial Soft Tissue Changes and Their Clinical Perceptibility Following Miniscrew-Assisted Rapid Palatal Expansion (MARPE)

Key Details

Gender

All

Age Range

16 Years - 25 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-11-01

Completion Date

2028-05-01

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

DEVICE

Miniscrew-Assisted Rapid Palatal Expansion (MARPE)

MARPE is performed as part of routine orthodontic treatment based on an independent clinical indication. The study does not assign or modify the treatment. Three-dimensional facial scans are obtained before expansion (T0), immediately after active expansion (T1), and at the third month of retention (T2) to evaluate facial soft tissue changes.

Locations (1)

Adiyaman University Faculty of Dentistry, Department of Orthodontics

Adıyaman, Adıyaman Province, Turkey (Türkiye)