Twin Block Appliance in Incremental Versus Maximum Bite Advancement in Skeletal Class II

NCT ID: NCT04562545

Last Updated: 2020-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-09-15

Brief Summary

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The aim of this study is to compare to different protocols to treat Class II malocclusion in growing subjects using the twin block appliance

Detailed Description

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* Patients will be clinically and radio-graphically examined for eligibility
* Eligible patients will be randomly assigned to one of two groups:

* Control Group: Twin Block Appliance fabricated to Maximum Bite Advancement group
* Intervention Group: Twin Block Appliance fabricated for Incremental Bite Advancement group
* Records will be taken and impressions will be made and poured. In the control group, bite registration will be made with maximum mandibular advancement. In the intervention group, bite registration is made to habitual bite to make a modified twin block.
* Patients will be recalled every 6 weeks for 8 months for monitoring and reactivation of the appliance.

Conditions

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Mandibular Retrognathism Mandibular Hypoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Type: Two arm, parallel, randomized clinical trial. allocation ratio 1:1 framework: superiority
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessor will carry out measurements blindly on pre-operative and post-operative radio-graphs

Study Groups

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Maximum Bite Advancement

Group Type ACTIVE_COMPARATOR

Twin Block Appliance set to maximum bite

Intervention Type DEVICE

a traditional twin block set to maximum bite advancement at start of treatment

Incremental Bite Advancement

Group Type EXPERIMENTAL

Modified Twin Block

Intervention Type DEVICE

a modified twin block design including jack screws to facilitate incemental advancement

Interventions

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Modified Twin Block

a modified twin block design including jack screws to facilitate incemental advancement

Intervention Type DEVICE

Twin Block Appliance set to maximum bite

a traditional twin block set to maximum bite advancement at start of treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Growing Female Patient
* Skeletal Class II Malocclusion due to deficient mandible
* Overjet of 7 to 10 mm
* Short or normal vertical facial pattern
* No previous orthodontic nor orthopedic treatment

Exclusion Criteria

* Syndromes or Chronic Illness
* Skeletal Class II Malocclusion due to excessive maxilla
* Vertical skeletal growth pattern
* Habits
Minimum Eligible Age

9 Years

Maximum Eligible Age

13 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Khaled Mohamed Ali Hussein

Post Graduate Student, Department of Orthodontics, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Khaled M. Hussein, B.D.S

Role: CONTACT

+201558332038

Sahar Taher, PhD

Role: CONTACT

Facility Contacts

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Khaled M. Hussein, B.D.S

Role: primary

+201558332038

Sahar Taher, PhD

Role: backup

References

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DeVincenzo JP, Winn MW. Orthopedic and orthodontic effects resulting from the use of a functional appliance with different amounts of protrusive activation. Am J Orthod Dentofacial Orthop. 1989 Sep;96(3):181-90. doi: 10.1016/0889-5406(89)90454-x.

Reference Type BACKGROUND
PMID: 2773861 (View on PubMed)

Banks P, Wright J, O'Brien K. Incremental versus maximum bite advancement during twin-block therapy: a randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2004 Nov;126(5):583-8. doi: 10.1016/j.ajodo.2004.03.024.

Reference Type BACKGROUND
PMID: 15520691 (View on PubMed)

Other Identifiers

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CEBD-CU-2020-09-08

Identifier Type: -

Identifier Source: org_study_id

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