A clinical trial to assess the effectiveness of miniplate surgical treatment to bring the upper jaw forwards in 11-14 years old children

A multicentre randomised clinical trial to investigate whether Bone Anchored Maxillary Protraction (BAMP) reduces the need for orthognathic (facial) surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93900866

Enrollment

Registered

2014-09-19

Start date

2015-07-06

Completion date

Unknown

Last updated

2024-11-12

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

Conditions

Oral and maxillofacial surgery and orthodontics Oral Health

Interventions

Group 1: BAMP surgery Group 2: Control/no treatment BAMP consists of small metal plates that are inserted from inside the mouth into the front part of the cheekbone bone next to the upper molars on e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 11-14 years old 2. Class III skeletal pattern with reverse bite of at least 1mm 3. Dentally fit 4. Written consent

Exclusion criteria

Exclusion criteria: 1. Cleft lip and or palate or craniofacial syndrome 2. Reverse bite greater than 6mm 3. Lower jaw asymmetric 4. Muscular dystrophy (weakness) 5. Patient smokes

Design outcomes

Primary

Measure	Time frame
1. Need for orthognathic surgery later 2. Amount of forward movement of the maxilla (upper jaw) to correct the reverse bite 3. Reverse overjet (bite) correction Need for orthognathic surgery will be measured through consultant clinical panel consensus method using patient records. Forward movement of the maxilla will be measured from lateral cephalogram radiographs. Reverse overbite correction will be measured from plaster study models of the patients? teeth using a metal ruler. The outcomes will be measured at baseline, 1 and 3 years follow-up.	—

Measure

Time frame

1. Need for orthognathic surgery later 2. Amount of forward movement of the maxilla (upper jaw) to correct the reverse bite 3. Reverse overjet (bite) correction Need for orthognathic surgery will be measured through consultant clinical panel consensus method using patient records. Forward movement of the maxilla will be measured from lateral cephalogram radiographs. Reverse overbite correction will be measured from plaster study models of the patients? teeth using a metal ruler. The outcomes will be measured at baseline, 1 and 3 years follow-up.

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Secondary

Measure	Time frame
1. Facial aesthetic improvement 2. Patient discomfort log following surgery 3. Operating time for the BAMP surgery 4. BAMP - post operative infection rates and plate failure rates Facial aesthetic improvement will be measured using panel consensus of facial profiles photographs. Patient discomfort log will be recorded on a 7 point Likert scale with 1 = no pain at all to 7 severe pain. Operating time for BAMP surgery will be recorded from the theatre time log. Post operative infection rates and plate failure rates will be recorded from the patient notes. The outcomes will be measured at baseline, 1 and 3 years follow-up.	—

Measure

Time frame

1. Facial aesthetic improvement 2. Patient discomfort log following surgery 3. Operating time for the BAMP surgery 4. BAMP - post operative infection rates and plate failure rates Facial aesthetic improvement will be measured using panel consensus of facial profiles photographs. Patient discomfort log will be recorded on a 7 point Likert scale with 1 = no pain at all to 7 severe pain. Operating time for BAMP surgery will be recorded from the theatre time log. Post operative infection rates and plate failure rates will be recorded from the patient notes. The outcomes will be measured at baseline, 1 and 3 years follow-up.

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Countries

England, United Kingdom

Outcome results

None listed

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