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

A comparison of the effectiveness of fixed versus removable functional appliances in the treatment of Class II malocclusion in children: a randomised clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11717011

Enrollment

Registered

2016-06-03

Start date

2017-02-01

Completion date

Unknown

Last updated

2023-11-20

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

Conditions

Class II division 1 malocclusion Oral Health

Interventions

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 fo

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

England, United Kingdom

Contacts

Public ContactMoaiyad Moussa Pacha

m.moussapacha@qmul.ac.uk+44 (0)20 7882 8629

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026