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

Not Applicable

Completed

• Conditions: Oral and maxillofacial surgery and orthodontics; Oral Health

• Registration Number: ISRCTN93900866
• Lead Sponsor: Tameside Hospital NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-19
• Study Completion: 2022-10-01
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 57

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Need for orthognathic surgery later<br>2. Amount of forward movement of the maxilla (upper jaw) to correct the reverse bite<br>3. Reverse overjet (bite) correction<br><br>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.

Secondary Outcome Measures

Name	Time	Method
1. Facial aesthetic improvement<br>2. Patient discomfort log following surgery<br>3. Operating time for the BAMP surgery<br>4. BAMP - post operative infection rates and plate failure rates<br><br>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.