Early orthodontic treatment for reverse bite: an orthopaedic facemask treatment for children < 10 years old reduces the need for jaw surgery in the late teens

Early class III protraction facemask treatment reduces the need for orthognathic surgery: a multicentre, two-arm, parallel randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10014340

Enrollment

Registered

2016-05-12

Start date

2004-01-01

Completion date

Unknown

Last updated

2020-02-03

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

Conditions

Class III reverse bite with a class III skeletal face profile (small upper jaw and large lower jaw) Oral Health

Interventions

Random allocation to protraction facemask treatment or no treatment/control groups. The intervention was a protraction facemask treatment which is a head brace attached to an upper pl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 7-9 years old 2. Class III skeletal pattern 3. 3 or 4 incisors in crossbite

Exclusion criteria

Exclusion criteria: 1. Non-white Caucasian origin 2. Cleft lip and or palate or craniofacial syndrome 3. Maxillomandibular plane angle of more than 35 degrees 4. Lower face height greater than 70 mm 5. Previous temporomandibular pain dysfunction syndrome

Design outcomes

Primary

Measure	Time frame
1. Need for orthognathic surgery: measured at 6 year follow-up using expert panel consensus 2. Skeletal change: measured from lateral cephalogram facial radiographs at 15 months, 3 years and 6 years follow-up 3. Dental change, correction of reverse bite: measured from dental models at 15 months, 3 years and 6 years follow-up	—

Secondary

Measure	Time frame
1. Self esteem: using Piers Harris questionnaire at 15 months, 3 years and 6 years follow-up 2. Oral aesthetic impact: using OASIS questionnaire at 15 months, 3 years and 6 years follow-up 3. Temporomandibular joint signs or symptoms: clinical examination at 15 months and 3 years	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026