Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency

Not Applicable

• Conditions: Class II Division 1 Malocclusion
• Interventions: Device: modified twin block appliance; Device: twin block appliance

• Registration Number: NCT03635463
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency.

Detailed Description

in this randomized controlled trail there are 2 groups , the first group will receive modified twin block appliance ,in the second group will receive conventional twin block appliance . the follow up period will be 9 months till mandibular growth occur . the assessment will be through a questionnaire on the number of hours the appliance is worn each day , and another questionnaire assessing the difficulty of speech and aesthetics . Also by, photographs, x-rays and study models preoperative and post operative.

Study Timeline

• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Study Start: 2018-12
• Last Update Posted: 2018-12-03
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Skeletal Class II relationship (ANB > 4°).
2. Mandibular retrognathy (SNB < 78°).
3. Overjet ≥ 5 mm.
4. Minimal crowding in dental arches (≤4 mm).
5. Class II molar relation.
6. Growing female patients.
7. Patients with CMV3 maturation stage of the cervical verbrae.

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Exclusion Criteria

1. No history of orthodontic treatment either prior to or during functional Appliance therapy.
2. Posterior cross bites or severe maxillary transverse deficiency.
3. Severe facial asymmetry determined by clinical or radiographical examination.
4. Poor oral hygiene.
5. Systemic diseases that may affect the orthodontic treatment results.
6. Patients past their peak growth spurt.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
modified twin block appliance group	modified twin block appliance	modified twin block appliance group , this group will receive the modified appliance and followed up every month for 9 months
twin block appliance	twin block appliance	this group will receive conventional twin block appliance and followed up every month for 9 months.

Primary Outcome Measures

Name	Time	Method
enhancing mandibular skeletal growth	9 months	it will be assessed by measuring the incremental growth by quick ceph (mm)

Secondary Outcome Measures

Name	Time	Method
Improvement of soft tissue profile	9 months	quick ceph (mm)
Patient's compliance	9 months	table chart (no of hours/day)
dentoalveolar changes	9 months	quick ceph (mm)