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NCT Number: NCT06792513

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

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.

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Key information

Conditions

Anterior Crossbite

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry

Antalya, Konyaaltı, 07058, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Other names: Z spring appliance

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Changes in Analogue Cast Model Measurements Before and After Treatment

    Time frame: 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).

  2. 3D model measurements

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ozge Gungor

Other

Collaborators

  • Akdeniz University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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