Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency

Not Applicable

Recruiting

• Conditions: Mandible Small; Angle Class II; Malocclusion
• Interventions: Device: removable twin block; Device: modified Fixed twinblock

• Registration Number: NCT05993156
• Lead Sponsor: Cairo University

Brief Summary

Effects of modified fixed twin block versus removable twin block on skeletal class 2 growing patients with mandibular deficiency:

A Randomized Clinical Trial

Detailed Description

The main objective of the study is to evaluate the effects of the modified fixed TB on class 2 growing cases and to compare its effect to the conventional removable TB

Research question Does the modified fixed twin block have the same effects as removable twin block during treatment of skeletal class 2 growing patients with mandibular deficiency?

PICO P: Growing skeletal class 2 patients with deficient mandible I : Modified Fixed Twin block C: Conventional removable Twin block

O :

Primary outcome:

Overjet

Secondary outcome:

Soft tissue Profile Antro-posterior mandibular position Mandibular length Antro-posterior maxillary position Upper and lower Incisors inclinations Durability of the appliance Patient Acceptance

Hypothesis:

There is no difference between the modified fixed or removable Twin block appliance regarding overjet reduction, dentoskeletal effects and patient perception.

8. Trial design: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-07-06
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-13
• Last Update Submitted: 2023-08-13
• Study First Posted: 2023-08-15
• Last Update Posted: 2023-08-15
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Skeletal Class 2 malocclusion cases (ANB ≥ 5 degrees)
• Overjet ≥ 5 mm
• Growing patients (CVMS 3 or 4)

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Exclusion Criteria

• Skeletally mature patients 15 years old or above
• Patients with normal mandible and only protruded upper incisors.
• Syndromic, cleft patients and patients with dental anomalies
• Previous orthopaedic or orthodontic treatment
• No sex predilection.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Removable twin block group	removable twin block	participants would receive conventional removable twin block for correction of class II malocclusion for 9 months
Fixed twin block group	modified Fixed twinblock	participants would receive a modified fixed twin block for correction of class II malocclusion for 9 months

Primary Outcome Measures

Name	Time	Method
Over jet reduction	9 months	the horizontal distance between upper and lower incisors

Secondary Outcome Measures

Name	Time	Method
lower incisor inclination	9 months	inclination of lower incisors on the mandibular plane
Effective mandibular length	9 months	distance from condylon to the Pogonion points

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt