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A Comparison of the Effectiveness of Two Types of Myofunctional Appliances

NCT ID: NCT05371691

Last Updated: 2023-11-28

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

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2024-08-10

Brief Summary

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A randomized clinical trial is set out to compare the effectiveness of two types of functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth).

Detailed Description

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It is a multicenter randomized clinical trial with two arms parallel group. The patients will be randomly divided into two groups, group one: Myobrace appliance will be used while, and group two Twin-block appliances will be used. Cephalometric x-ray will be taken before starting the treatment (T1) and at the end of treatment (T2) at 9 months. The effectiveness of the two appliances will be assessed and measured comparing the difference in the cephalometric X-ray before and after treatment.

Conditions

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Tooth Position Anomalies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinding to treatment allocation is possible only for the outcomes assessor because the clinicians could know the intervention. All the trial documents will be labeled with the study ID number, which be used for participant identification and data collection without unmasking the allocation group.

Study Groups

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Myobrace group

Myobrace appliance will be used for children who have Cl.II div.a malocclusion

Group Type EXPERIMENTAL

Myofunctional appliance

Intervention Type DEVICE

Myifunctional appliance will be used for growing patients who have Cl.II div.1 malocclusion, two types of appliances are involved myobrace and twin=block appliance

Twin-block group

Twin-block appliance will be used for children who have Cl.II div.a malocclusion

Group Type EXPERIMENTAL

Myofunctional appliance

Intervention Type DEVICE

Myifunctional appliance will be used for growing patients who have Cl.II div.1 malocclusion, two types of appliances are involved myobrace and twin=block appliance

Interventions

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Myofunctional appliance

Myifunctional appliance will be used for growing patients who have Cl.II div.1 malocclusion, two types of appliances are involved myobrace and twin=block appliance

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Growing children who need myofunctional appliance.
2. Cl II div. 1 malocclusion.
3. No previous orthodontic or orthopaedic treatments.

Exclusion Criteria

1. Patients with systemic involvement.
2. Congenital malformations such as cleft lip and palate.
3. Facial deformities.
4. Finger sucking habit will be excluded
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Mushriq F. Abid

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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College of Dentistry-University of Baghdad

Baghdad, Al-Rusafa, Iraq

Site Status RECRUITING

College of Dentisry-University of Baghdad

Baghdad, , Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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Mushriq Abid

Role: CONTACT

[email protected]
7718800706 ext. 00964

Mushriq Abid

Role: CONTACT

[email protected]

Facility Contacts

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Mushriq Abid

Role: primary

Mushriq Abid, PhD

Role: primary

Other Identifiers

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387421

Identifier Type: -

Identifier Source: org_study_id