The Effectiveness of Acrylic and Clear Aligners in the Treatment of Anterior Crossbite in Children

Not Applicable

Completed

• Conditions: Anterior Crossbite

• Registration Number: NCT06792513
• Lead Sponsor: Ozge Gungor

Brief Summary

To evaluate the treatment efficacy, treatment duration, and cephalometric changes, as well as the impact on quality of life, of clear aligners and labiolingual spring Hawley appliances in the treatment of pediatric patients with anterior crossbite.

Detailed Description

Two groups were treated with clear aligners and labiolingual springs Hawley and the study consisted of 30 patients, 15 patients in each group. Cast analysis and cephalometric analysis were performed at pretreatment and posttreatment. Quality of life was assessed at the end of treatment for both groups.

Study Timeline

• Study Start: 2024-06-10
• Primary Completion: 2024-06-10
• Study Completion: 2024-11-10
• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-24
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. In the mixed dentition phase, aged between 7-12 years
2. With a dental Class I molar relationship according to Angle's classification
3. ANB within the normal range i.e. (the crossbite will be diagnosed as dental)
4. Exhibiting anterior crossbite (AC) in at least one permanent incisor in the sagittal plane
5. No prior orthodontic treatment for any reason
6. No history of maxillofacial trauma
7. No systemic diseases or syndromes that may interfere with treatment
8. Able to attend regular appointments and cooperate with instructions throughout the treatment process

Exclusion Criteria

1. Patients with functional anterior crossbite associated with mandibular functional shift
2. Patients with clinically evident retrognathia or prognathia of the maxilla or mandible
3. Patients with severe gingivitis or periodontitis
4. Patients with known allergies to the materials to be used in the treatment
5. Patients with severe dental anomalies (e.g., supernumerary teeth, missing teeth, dental malformations)
6. Patients with serious emotional or psychological issues that may hinder treatment compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Cephalometric Measurements Before and After Treatment Assessed Using Dolphin Imaging Software (Version 11.95)	3 months	Comparison of cephalometric measurements (e.g., ANB, FMA, U1-NA angle, overjet, and overbite) between the two groups at pre-treatment and post-treatment periods. Measurements will be performed using Dolphin Imaging Software version 11.95, with units reported in degrees and millimeters as applicable.
Changes in Oral Health-Related Quality of Life Assessed Using the Child Oral Health Impact Profile-Short Form 19 (COHIP-SF-19)	3 months	COHIP-SF-19 scores will be assessed at the end of the treatment period to evaluate changes in oral health-related quality of life. The scale ranges from 0 to 76, with higher scores indicating worse oral health-related quality of life.

Secondary Outcome Measures

Name	Time	Method
Changes in Analogue Cast Model Measurements Before and After Treatment	3 months	Comparison of analogue model measurements, including parameters such as arch depth and arch length, between the two groups at pre-treatment and post-treatment periods. Measurements will be performed using calipers on analogue cast models. Units of measure include millimeters (mm).
3D model measurements	3 months	Comparison of the measurements of the 3D digital model analysis of the two groups at the pre-treatment and at the post-treatment.

Trial Locations

Locations (1)

Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry; 🇹🇷 Antalya, Konyaaltı, Turkey