Palatal Versus Buccal Protraction Using Plates Assisted With Facemask in Growing Class III Patients

NCT ID: NCT06452368

Last Updated: 2024-06-14

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-11-20

Brief Summary

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to compare Palatal and buccal protraction using plates assisted with facemask in growing class III patients

Detailed Description

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A randomized controlled clinical trial was adopted in this study. A total of 20 growing Class III patients were selected from patients seeking orthodontic treatment. The participants were recruited from the department of Orthodontics at Faculty of Dentistry, Mansoura University. No active advertisement was used for participant recruitment, and instead, a convenience sample was formed. Prior to participating in the study, the purpose of the study was explained to the parents of the children and informed consents and assents were obtained according to the guidelines on human research adopted by the Research Ethics Committee Faculty of Dentistry, Mansoura University

Conditions

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Class III Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Palatal protraction

Palatal plate assisted with facemask

Group Type ACTIVE_COMPARATOR

facemask

Intervention Type DEVICE

Fixation of miniplates by four screws in the maxilla and protraction by using facemask

Buccal protraction

Buccal plate assisted with facemask

Group Type ACTIVE_COMPARATOR

facemask

Intervention Type DEVICE

Fixation of miniplates by four screws in the maxilla and protraction by using facemask

Interventions

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facemask

Fixation of miniplates by four screws in the maxilla and protraction by using facemask

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Growing patients with age ranged between 8-13 years old.
* Patients should have examination: Class III malocclusion due to maxillary retrusion as verified by clinical and radiographic examination; SNA \<79 and ANB angle \< -1.
* Good likelihood of recall availability.

Exclusion Criteria

* Vertical skeletal mal relationship.
* History of previous orthodontic/orthopedic treatment.
* Bad habits that may jeopardize the appliance.
* Patients with systemic diseases
* Congenital deformities such as cleft lip and/or palate.
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Adel Raghib

Phd researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohamed Adel Raghib

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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M04020822

Identifier Type: -

Identifier Source: org_study_id

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