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

NCT ID: NCT06792513

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2024-11-10

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.

Conditions

Anterior Crossbite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clear aligner (group treated with clear aligner)

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

Group Type: EXPERIMENTAL

Clear Aligner

Intervention Type: 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 appliances (group treated with labiolingual spring Hawley appliances)

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

Group Type: EXPERIMENTAL

Labiolingual Spring Hawley Appliance

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Z spring appliance

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: collaborator

Ozge Gungor

OTHER

Sponsor Role: lead

Responsible Party

Ozge Gungor

PhD, DDS, Clinical Associate Professor of Pedodontics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Özge Güngör, PhD, DDS, Assoc. Prof.

Role: STUDY_DIRECTOR

Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry

Locations

Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry

Antalya, Konyaaltı, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AUBNG001

Identifier Type: -

Identifier Source: org_study_id