Comparison of the fixed versus the removable functional braces in the treatment of children with sticking out top front teeth

Not Applicable

Completed

• Conditions: Class II division 1 malocclusion; Oral Health

• Registration Number: ISRCTN11717011
• Lead Sponsor: Barts Health NHS Trust

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37409988/ (added 07/07/2023) 2023 Results article in https://doi.org/10.1093/ejo/cjad065 (added 07/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-03
• Study Completion: 2023-07-31
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Patients medically and dentally fit
2. Adolescent patients aged 10-14 years
3. Class II malocclusion, with overjet of = 7mm
4. Neutral or hypo-divergent facial type, with mandibular plane angle (ML/NSL) =39? (Pancherz, 1982)

Exclusion Criteria

1. Associated craniofacial syndrome
2. Serious or compromised medical conditions
3. Previous orthodontic treatment
4. Dental extractions or missing permanent teeth, except the third molars

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The effectiveness in terms of morphological changes (skeletal, soft tissue and dento-alveolar)<br> 2. The duration of functional treatment until the full reduction of the overjet (0-2mm)<br><br> The measurements will be undertaken at the following points:<br> 1. T0, at the baseline and before commence treatment<br> 2. T1, at the end of functional phase of treatment and directly after removal the functional brace (6-12 months), when the sticking out teeth (the overjet) is a full reduced to within normal value (0-2 mm)<br> 3. T2, if the children is assessed to have a second phase of treatment using train-track brace, then a third measurements will be undertaken after achieving an ideal occlusion relationship (18-30 months)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. The impact on patient-reported perception (function; compliance; harms; quality of life; self-esteem; and function)<br> 2. Cost-effectiveness<br><br> The measurements will be undertaken at the following points:<br> 1. T0, at the baseline and before commence treatment<br> 2. T1, at the end of functional phase of treatment and directly after removal the functional brace (6-12 months), when the sticking out teeth (the overjet) is a full reduced to within normal value (0-2 mm)<br> 3. T2, if the children is assessed to have a second phase of treatment using train-track brace, then a third measurements will be undertaken after achieving an ideal occlusion relationship (18-30 months)<br>