Clinical trial NCT06792513: The Effectiveness of Acrylic and Clear Aligners in the Treatment of Anterior Crossbite in Children
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Crossbite
Keywords: anterior crossbite
cephalometric analysis
clear aligners
labiolingual spring Hawley
quality of life
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: Akdeniz University
First posted: 2025-01-24
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Cephalometric Measurements Before and After Treatment Assessed Using Dolphin Imaging Software (Version 11.95)
timeFrame: 3 months
measure: Changes in Oral Health-Related Quality of Life Assessed Using the Child Oral Health Impact Profile-Short Form 19 (COHIP-SF-19)
timeFrame: 3 months
Secondary outcomes:
measure: Changes in Analogue Cast Model Measurements Before and After Treatment
timeFrame: 3 months
measure: 3D model measurements
timeFrame: 3 months
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry
state: Konyaaltı
Study officials:
affiliation: Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry
name: Özge Güngör, PhD, DDS, Assoc. Prof.
role: STUDY_DIRECTOR
References: