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Clinical Trials/NCT05993156
NCT05993156UnknownNot Applicable

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

Cairo University1 site in 1 country24 target enrollmentStarted: December 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
24
Locations
1
Primary Endpoint
Over jet reduction

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
9 Years to 15 Years (Child)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

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.

Arms & Interventions

Removable twin block group

Active Comparator

participants would receive conventional removable twin block for correction of class II malocclusion for 9 months

Intervention: removable twin block (Device)

Fixed twin block group

Experimental

participants would receive a modified fixed twin block for correction of class II malocclusion for 9 months

Intervention: modified Fixed twinblock (Device)

Outcomes

Primary Outcomes

Over jet reduction

Time Frame: 9 months

the horizontal distance between upper and lower incisors

Secondary Outcomes

  • lower incisor inclination(9 months)
  • Effective mandibular length(9 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Omar yousry mahmoud mostafa

primary investigator, assistant lecturer

Cairo University

Study Sites (1)

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