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

August 13, 2023 updated by: Omar yousry mahmoud mostafa, Cairo University

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

A Randomized Clinical Trial

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Removable twin block group
participants would receive conventional removable twin block for correction of class II malocclusion for 9 months
Device: removable twin block
Conventional Removable Clark twin block myofunctional appliance
Other Names:
  • R.T.B.
Experimental: Fixed twin block group
participants would receive a modified fixed twin block for correction of class II malocclusion for 9 months
Device: modified Fixed twinblock
modified fixed twin block functional appliance, with cemented bands on the first molars
Other Names:
  • F.T.B.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Over jet reduction
Time Frame: 9 months
the horizontal distance between upper and lower incisors
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective mandibular length
Time Frame: 9 months
distance from condylon to the Pogonion points
9 months
lower incisor inclination
Time Frame: 9 months
inclination of lower incisors on the mandibular plane
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

August 13, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-3-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

results and statistical data would be published and IPD would be available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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