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

The Effectiveness of Acrylic and Clear Aligners in the Treatment of Anterior Crossbite in Children and Evaluatıon of the Effects of These Treatments on Quality of Life

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.

Study Overview

• Status: Completed
• Conditions: Anterior Crossbite
• Intervention / Treatment: Device: Clear Aligner; Device: Labiolingual Spring Hawley Appliance

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konyaaltı
    • Antalya, Konyaaltı, Turkey, 07058
      • Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clear aligner (group treated with clear aligner); 2 parallel groups one treated with clear aligner and other treated using labiolingual spring Hawley appliances	Device: Clear Aligner; 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.
Experimental: Labiolingual spring Hawley appliances (group treated with labiolingual spring Hawley appliances); 2 parallel groups one treated with clear aligner and other treated using labiolingual spring Hawley appliances	Device: Labiolingual Spring Hawley Appliance; 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.; Other Names: Z spring appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D model measurements	Comparison of the measurements of the 3D digital model analysis of the two groups at the pre-treatment and at the post-treatment.	3 months
Changes in Analogue Cast Model Measurements Before and After Treatment	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).	3 months

Collaborators and Investigators

• Sponsor: Ozge Gungor
• Collaborators: Akdeniz University
• Investigators: Study Director: Özge Güngör, PhD, DDS, Assoc. Prof., Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): November 10, 2024

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 25, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; clear aligners; anterior crossbite; cephalometric analysis; labiolingual spring Hawley
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: AUBNG001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A final decision regarding the sharing of individual participant data (IPD) has not yet been made. Appropriate data-sharing protocols will be evaluated in the future before reaching a decision.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No