En Masse Distaliaztion Via Skeletal Anchorage

NCT ID: NCT05245929

Last Updated: 2022-02-18

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

2021-01-05

Study Completion Date

2024-01-31

Brief Summary

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Comparing the efficacy and performance of two conventionally anchored distalizers after modifying them to be skeletally anchored. En masse distalization is attempted by consolidating the posterior maxillary segment "first premolar to second molar" as one unit.

Detailed Description

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Conditions

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Orthodontic Appliance Complication, Angle Class II Patients, Distalization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Skeletally anchored Distal Jet appliance

Group Type ACTIVE_COMPARATOR

Distalization

Intervention Type DEVICE

Distalizing the posterior maxillary segment

Skeletally anchored Hyrax screw distalizer

Group Type ACTIVE_COMPARATOR

Distalization

Intervention Type DEVICE

Distalizing the posterior maxillary segment

Interventions

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Distalization

Distalizing the posterior maxillary segment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Full set of permanent teeth present, except for third molar
* Bilateral Class II malocclusion with a mesial migration of maxillary posterior teeth
* No systemic conditions interfering with treatment, as reported by patient
* No previous Orthodontic treatment
* Good Oral Hygiene
* No use of any for of anti-inflammatory drugs

Exclusion Criteria

* Patient who required surgery to correct skeletal discrepancies
* Patient with congenital dentoskeletal disorders
* Missed or Mutilated teeth in Maxillary arch
* Patients with poor oral hygiene
Minimum Eligible Age

14 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Kadry Ahmed Algariah

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar University, faculty of dental medicine orthodontic clinic

Cairo, Nasr City, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Ramadan Abu Shahba, Professor

Role: primary

01012624339

Other Identifiers

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Dist007

Identifier Type: -

Identifier Source: org_study_id

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