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

NCT06792513 | Completed

• 1 other identifier: AUBNG001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Crossbite

Keywords

anterior crossbite; cephalometric analysis; clear aligners; labiolingual spring Hawley; quality of life

Outcome Measures

Primary Outcomes (2)

• Changes in Cephalometric Measurements Before and After Treatment Assessed Using Dolphin Imaging Software (Version 11.95)

  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.

  3 months

• Changes in Oral Health-Related Quality of Life Assessed Using the Child Oral Health Impact Profile-Short Form 19 (COHIP-SF-19)

  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.

  3 months

Secondary Outcomes (2)

• Changes in Analogue Cast Model Measurements Before and After Treatment

  3 months

• 3D model measurements

  3 months

Study Arms (2)

Clear aligner (group treated with clear aligner)

EXPERIMENTAL

2 parallel groups one treated with clear aligner and other treated using labiolingual spring Hawley appliances

Device: Clear Aligner

Labiolingual spring Hawley appliances (group treated with labiolingual spring Hawley appliances)

EXPERIMENTAL

2 parallel groups one treated with clear aligner and other treated using labiolingual spring Hawley appliances

Device: Labiolingual Spring Hawley Appliance

Interventions

Clear Aligner DEVICE

In this intervention, clear aligners were digitally designed using three-dimensional models for the upper jaw. Attachments were applied to the patients, specifically placed on the incisors exhibiting a crossbite relationship and on the permanent first molars in the posterior region. The series of clear aligners were replaced every 10 days. The aligners were used full-time, except during meals and tooth brushing.

Clear aligner (group treated with clear aligner)

Labiolingual Spring Hawley Appliance DEVICE

In this intervention, a custom-made labiolingual spring Hawley appliance was designed for the upper jaw. It included two Adams clasps, a vestibular arch, and an active labiolingual spring positioned on the palatal side of the incisor in crossbite. The spring was activated every 10 days. The appliance was used full-time, except during meals and tooth brushing.

Also known as: Z spring appliance

Labiolingual spring Hawley appliances (group treated with labiolingual spring Hawley appliances)

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ozge Gungor: lead
• Akdeniz University: collaborator

Study Sites (1)

Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry

Antalya, Konyaaltı, 07058, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Orthodontic Appliances, Removable

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Özge Güngör, PhD, DDS, Assoc. Prof.

  Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, DDS, Clinical Associate Professor of Pedodontics

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 24, 2025
• Study Start: June 10, 2024
• Primary Completion: June 10, 2024
• Study Completion: November 10, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)