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

Skeletal, functional and dental changes during treatment of mild to moderate class II malocclusions with fixed class II correctors: A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57079737
Enrollment
90
Registered
2022-10-21
Start date
2014-06-04
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Class II malocclusion Oral Health

Interventions

The research is designed as a randomized controlled clinical trial to evaluate dentofacial and dentoalveolar changes following mild to moderate Class II malocclusion correction using different fixed C
T1: Baseline records for all groups at enrolment date. T2: 12 months after T1 (before full bonded orthodontic treatment for all groups). T3: 18 – 30 months after T2 (after debonding of orthodontic tre

Sponsors

University of Alberta
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. Evaluating gingival attachment and periodontal condition changes associated with FCC treatment, using Clinical assessment at all 4 assessment times (T1, T2, T3, T4) 2. Evaluate the FCCs impact on participants' quality of life associated with FCC treatment using a self-reported Questionnaire: 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).

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026