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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06792513
Enrollment
30
Registered
2025-01-24
Start date
2024-06-10
Completion date
2024-11-10
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Crossbite

Keywords

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

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.

Interventions

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.

DEVICELabiolingual 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.

Sponsors

Akdeniz University
CollaboratorOTHER
Ozge Gungor
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Cephalometric Measurements Before and After Treatment Assessed Using Dolphin Imaging Software (Version 11.95)3 monthsComparison 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 monthsCOHIP-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

MeasureTime frameDescription
Changes in Analogue Cast Model Measurements Before and After Treatment3 monthsComparison 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 measurements3 monthsComparison of the measurements of the 3D digital model analysis of the two groups at the pre-treatment and at the post-treatment.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026