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

• Register: ISRCTN
• Last refreshed on: 20 November 2023
• Main ID: ISRCTN11717011
• Date of registration: 03/06/2016
• Prospective Registration: Yes
• Primary sponsor: Barts Health NHS Trust
• Public title: Comparison of the fixed versus the removable functional braces in the treatment of children with sticking out top front teeth
• Scientific title: A comparison of the effectiveness of fixed versus removable functional appliances in the treatment of Class II malocclusion in children: a randomised clinical trial
• Date of first enrolment: 01/02/2017
• Target sample size: 80
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN11717011
• Study type: Interventional
• Study design: Randomised parallel-group study design with a positive control group (Treatment)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Moaiyad Moussa Pacha

• Name: Ama Johal

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Class II division 1 malocclusion
Oral Health

Intervention(s)

This trial will compare the effectiveness of an Hanks-Herbst fixed and Twin-Block removable functional appliance in the correction of Class II division 1 malocclusion. Treatment will be provided by four clinicians in a two-centre study in the UK: Bart’s NHS Health Trust and East Kent Hospitals University NHS Foundation Trust. Moreover, an independent data monitoring committee (DMC) will be assigned, and the trial will conform to the recommendations of the UK’s Medical Research Council for good clinical practice and in line with CONSORT guidelines (Schulz et al., 2010).

Patients who fulfil the selection criteria and are willing to participate will be asked to complete an assent form and their parents a consent form, after reading a participant information leaflet. Treatment allocation will be performed centrally at Queen Mary University. The duration of participants in the trial will be 12-36 months. This includes the length of functional treatment phase (6-12 months) followed by the second phase of FA treatment (12-18 months) if the clinician decides that it is necessary to achieve an optimal occlusal relationship.

Participants will randomly (like tossing a coin) be allocated to one of the two different functional brace options: Fixed Herbst brace OR Twin Block brace. To improve the quality of the study neither the child or the researcher will decide or know which brace the child will receive.

At the first visit, and in the line of routine orthodontic practice, the following procedures will be undertaken in order to best help decide on child treatment:
1. Mouldings of child’s teeth and bite, using a putty material (5 minutes to complete)
2. An X-ray for child’s jaws and t

Primary Outcome(s)

1. The effectiveness in terms of morphological changes (skeletal, soft tissue and dento-alveolar)
2. The duration of functional treatment until the full reduction of the overjet (0-2mm)

The measurements will be undertaken at the following points:
1. T0, at the baseline and before commence treatment
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)
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)

Secondary Outcome(s)

1. The impact on patient-reported perception (function; compliance; harms; quality of life; self-esteem; and function)
2. Cost-effectiveness

The measurements will be undertaken at the following points:
1. T0, at the baseline and before commence treatment
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)
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)

Secondary ID(s)

Internal Project Reference of QMUL: DI/PR/16/005

Source(s) of Monetary Support

Queen Mary University of London, Barts Health NHS Trust

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; North West - Greater Manchester South Research Ethics Committee, 06/12/2016, ref: 16/NW/0837

Results

• Results available: Yes
• Date Completed: 31/07/2023