Mandibular First Molar Distalization

NCT ID: NCT04229797

Last Updated: 2024-02-07

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-03-31

Brief Summary

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A clinical study to test the capability of the mini-screws inserted in the Mandibular buccal shelf area as an anchorage unit to distalize mandibular first molar for correction of mild to moderate Class III cases. The second aim was to detect if there is a difference in the amount of distalization in the presence of unerupted mandibular third molars, using the same technique.

Detailed Description

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Class III malocclusion in adults is one of the most complex malocclusions in clinical orthodontics. For adults, the ideal treatment option for Class III malocclusion is accomplished either by camouflage treatment in mild to moderate cases or orthognathic surgery in severe cases. Camouflage treatment for Class III malocclusion comprises three main techniques; Class III elastics, mandibular first molar distalization, or extraction of mandibular first premolars. Mandibular first molar distalization via the use of skeletal anchorage has the problem of increased failure rate of the inter-radicular temporary anchorage devices (TADs). Accordingly, a randomized clinical trial using extra radicular TADs in the Mandibular buccal shelf area was designed in the current research aiming to test the efficacy of such a technique in inducing mandibular molar distalization with decreased failure rate, and whether the presence of unerupted mandibular third molars will affect the distalization movement or not.

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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Comparator

Extraction of the unerupted third molars before distalization of mandibular first molar using Mandibular buccal shelf mini-screws.

Group Type ACTIVE_COMPARATOR

Mandibular distalization using extra-radicular miniscrews

Intervention Type PROCEDURE

Distalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars

Intervention

Leaving the unerupted third molars and distalizing using Mandibular buccal shelf mini-screws.

Group Type EXPERIMENTAL

Mandibular distalization using extra-radicular miniscrews

Intervention Type PROCEDURE

Distalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars

Interventions

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Mandibular distalization using extra-radicular miniscrews

Distalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Class III dental incisal relation.
* Dental canine and molar relation not more than half unit Class III.
* Presence of unerupted mandibular third molars on both sides.
* Skeletal Class I or mild Class III.
* Full Permanent dentition.
* Medically free subjects.

Exclusion Criteria

* Patients with systemic diseases or neuromuscular disorders.
* Retroclined lower incisors.
* Sever skeletal dysplasia.
* Patients with periodontal disease.
Minimum Eligible Age

16 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Khaled Makhlouf

Associate researcher NRC

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University

Cairo, Giza Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mohamed Kh Makhlouf

Role: CONTACT

=201001405334

Mostafa Mo Eldawlatly, Lecturer

Role: CONTACT

+201006619898

Facility Contacts

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Mohamed Kh Makhlouf

Role: primary

+201001405334

Other Identifiers

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MakhloufOrth

Identifier Type: -

Identifier Source: org_study_id

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