Effects of orthodontic treatment of a small lower jaw in adolescents using an Invisible bite advancement device (IBAD) study

Not Applicable

• Conditions: dental health; overjet correction; overbite correction; Small lower jaw correction; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624000742572
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-14
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

1. Sex: Male, female
2. Age range: Active pubertal growth evaluated by cervical vertebral maturation stages (CVMS). CVMS up to 3-4
3. Angle’s Class II division 1 malocclusion
4. ANB angle, equal to or more than 3.5° (The ANB angle measures the relative anteroposterior position between the maxilla and mandible. In normal individuals, the ANB angle is 2° ± 2°)
5. Overjet, equal to or more than 5 mm. The overjet is the extent of horizontal (anterioposterior) overlap of the maxillary central incisors over the mandibular central incisors (normal amount of overlap is between 2 and 4mm)
6. Mild-moderate dental crowding (1-4 mm, 4-7 mm respectively including the curve of Spee

Exclusion Criteria

1. Syndromic individuals (including cleft lip and palate)
2. Crossbite, severe crowding, hypodontia.
3. Temporomandibular joint disorder signs and symptoms
4. Previous Orthodontic treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dento-skeletal effects [Cephalometric and clinical assessment – numerical data from participants' cephalograms and clinical case files. Baseline: at 2 weeks post-randomization, and the end of the functional treatment phase ( equal to or more than 9 months)]

Secondary Outcome Measures

Name	Time	Method
User experience with the appliance using a patient questionnaire. The patient questionnaire is specifically designed for this study which will elicit patient experience with the appliance regarding appliance agreeability, and difficulty (appliance wearing, speech, pain, and so on).[Patient Questionnaire; the patient questionnaire is specifically designed for this study which will elicit patient experience with the appliance regarding appliance agreeability, and difficulty (wearing, speech, pain, and so on). At the end of the functional treatment phase ( equal to 9 months)]