Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study

NCT ID: NCT05555719

Last Updated: 2022-10-13

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-08-01

Brief Summary

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Fixed Functional Appliances comparisons in treatment of orthodontic class II malocclusion cases

Detailed Description

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Comparison between two types of fixed functional appliances, the first one is the Mandibular Protraction Appliances, while the second one was the PowerScope Appliance.

the treatment duration was 6 months the patients age was considered according to Baccetti et al, CVMI 3,4

Conditions

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Class II Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 treatment groups, both have class II malocclusion
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mandibular Protraction Appliance

the first group that received Mandibular Protraction Appliance

Group Type EXPERIMENTAL

Mandibular Protraction Appliance

Intervention Type DEVICE

Mandibular Protraction Appliance was installed on fixed orthodontic appliance

PowerScope Appliances

the first group that received PowerScope Appliances

Group Type EXPERIMENTAL

PowerScope Appliance

Intervention Type DEVICE

PowerScope Appliance was installed on fixed orthodontic appliance

Interventions

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Mandibular Protraction Appliance

Mandibular Protraction Appliance was installed on fixed orthodontic appliance

Intervention Type DEVICE

PowerScope Appliance

PowerScope Appliance was installed on fixed orthodontic appliance

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Skeletal and dental class II malocclusion with mandibular retrognathia, SNB\>= 4.
2. Patients in cervical vertebral maturation index 3 -5.
3. Age ranged from 13-16 years.
4. Overjet ≥ 5 mm.
5. Minimum crowding in dental arches requiring no extraction of any permanent teeth (excluding third molars).
6. Good oral hygiene and general health.
7. No previous orthodontic treatment or jaw's surgery.

Exclusion Criteria

* Class I skeletal malocclusion
* periodontally compromised patient
* patients have systemic diseases interfering with orthodontic treatment
Minimum Eligible Age

13 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Abo bakr fouad

Assistant lecturer, orthodontic department, Al Azhar university Cairo Boys

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abubakr M Fouad

Role: PRINCIPAL_INVESTIGATOR

Al-azhar university, Cairo - Egypt

Locations

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Abubakr Mohamed Fouad

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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346/1137/16/10/19

Identifier Type: -

Identifier Source: org_study_id

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