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

Primary Purpose

Malocclusion, Angle Class II, Mandible Small

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

modified Fixed twinblock

removable twin block

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring orthodontics, orthopedics, myofunctional appliance, Twinblock

Eligibility Criteria

9 Years - 15 Years (Child)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Removable twin block group

Fixed twin block group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Over jet reduction

the horizontal distance between upper and lower incisors

Secondary Outcome Measures

Effective mandibular length

distance from condylon to the Pogonion points

lower incisor inclination

inclination of lower incisors on the mandibular plane

Full Information

NCT ID

NCT05993156

First Posted

July 6, 2023

Last Updated

August 13, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05993156

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Actual)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malocclusion, Angle Class II, Mandible Small

Keywords

orthodontics, orthopedics, myofunctional appliance, Twinblock

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Removable twin block group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Fixed twin block group

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

modified Fixed twinblock

Other Intervention Name(s)

F.T.B.

Intervention Description

modified fixed twin block functional appliance, with cemented bands on the first molars

Intervention Type

Device

Intervention Name(s)

removable twin block

Other Intervention Name(s)

R.T.B.

Intervention Description

Conventional Removable Clark twin block myofunctional appliance

Primary Outcome Measure Information:

Title

Over jet reduction

Description

the horizontal distance between upper and lower incisors

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Effective mandibular length

Description

distance from condylon to the Pogonion points

Time Frame

9 months

Title

lower incisor inclination

Description

inclination of lower incisors on the mandibular plane

Time Frame

9 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Faculty of Dentistry

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ezat ahmed

Phone

0020223642705

rec@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

30672991

Citation

Alhammadi MS, Halboub E, Fayed MS, Labib A, El-Saaidi C. Global distribution of malocclusion traits: A systematic review. Dental Press J Orthod. 2018 Nov-Dec;23(6):40.e1-40.e10. doi: 10.1590/2177-6709.23.6.40.e1-10.onl. Erratum In: Dental Press J Orthod. 2019 Aug 01;24(3):113.

Results Reference

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PubMed Identifier

25296729

Citation

Burhan AS, Nawaya FR. Dentoskeletal effects of the Bite-Jumping Appliance and the Twin-Block Appliance in the treatment of skeletal Class II malocclusion: a randomized controlled trial. Eur J Orthod. 2015 Jun;37(3):330-7. doi: 10.1093/ejo/cju052. Epub 2014 Oct 8.

Results Reference

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PubMed Identifier

10565094

Citation

Caldwell S, Cook P. Predicting the outcome of twin block functional appliance treatment: a prospective study. Eur J Orthod. 1999 Oct;21(5):533-9. doi: 10.1093/ejo/21.5.533.

Results Reference

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Citation

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Results Reference

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PubMed Identifier

3422118

Citation

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PubMed Identifier

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Citation

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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

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