Effect of fixed growth modification correctors to treat mild to moderate misaligned bite (malocclusion) in adolescents

Not Applicable

• Conditions: Oral Health; Class II malocclusion

• Registration Number: ISRCTN57079737
• Lead Sponsor: niversity of Alberta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-21
• Last Update Posted: 25 March 2024
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1. Females aged 10-13 years old and males aged 10-14 years old, with first premolars and first permanent molars, fully erupted
2. Class II molar relationship or at least ½ cusp on both sides
3. Dental crowding = 6mm
4. Overbite = 1mm

Exclusion Criteria

1. Patients with missing/unerupted permanent first premolars and molars
2. Gingival recession (below CEJ)
3. TMJ trauma syndromes
4. History of Class II corrective orthodontics

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Evaluating maxillofacial, dentoalveolar bone remodeling, and tooth position changes associated with FCC treatment using fused MRI-CBCT images and fused CBCT-CBCT<br>2. Evaluate TMJ disc remodeling and disc-condyle relationship changes associated with FCC treatment using Fused MRI-CBCT images.<br>3. Evaluate TMJ clinical function changes associated with FCC treatment using a scoring scale to detect the severity of any dysfunction. <br><br>The dental assessments will be conducted at all time points, whereas the TMJ assessments will be conducted at T1, T2, T3 & T4.<br><br>Timepoints:<br>T1: Baseline records for all groups at the enrolment date<br>T2: 12 months after T1 (before full bonded orthodontic treatment for all groups)<br>T3: 18 – 30 months after T2 (after debonding of orthodontic treatment for all groups)<br>T4: 24 months after T3

Secondary Outcome Measures

Name	Time	Method
1. Evaluating gingival attachment and periodontal condition changes associated with FCC treatment, using Clinical assessment at all 4 assessment times (T1, T2, T3, T4) <br>2. Evaluate the FCCs impact on participants' quality of life associated with FCC treatment using a self-reported Questionnaire:<br>Patients will be provided with a questionnaire to evaluate their overall experience during the FCC treatment. Patients will be asked to answer this survey at all 4 assessment times (T1, T2, T3, T4).