Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars

NCT ID: NCT05592977

Last Updated: 2023-02-17

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2022-12-01

Brief Summary

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There is a scarcity in the current literature regarding such appliance and its effect on distalizing the first maxillary molar in absence of the second molar. Therefore, this study was made to evaluate the effect of bilateral distalization of upper first molars in a group of patients after extraction of maxillary second Molars using infra zygomatic mini implants.

Detailed Description

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The appliances available for distalization used to be mainly extraoral distalizing appliances which depended entirely on patient cooperation and compliance. Even after the emergence of intra-oral distalizing appliances they had adverse dentoalveolar effect such as anchorage loss and flaring of the upper anterior teeth. Thus, this study was made in order to evaluate the efficiency of our proposed appliance in the treatment of Class II patients while avoiding the adverse effects mentioned above.

Conditions

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Class II Malocclusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Due to the nature of the study, the operator and patients can't be blinded. Blinding of the outcome assessors can be done by sealing the name of the patient in the pre and post treatment radiographs used for analysis

Study Groups

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Intra-oral Distalizing Appliance

Two infra zygomatic mini-implants will be placed Bands will be cemented to upper first molars. The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars.

Orthodontic force 300 mg per side Will be delivered by Niti closed coil spring which is attached from infra zygomatic mini screw to the hook soldered to the wire framework.

Group Type EXPERIMENTAL

Intra-Oral Distalizing Device

Intervention Type DEVICE

The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. The anterior component of the inner bow is 3 mm free from the labial surface of anterior teeth

Interventions

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Intra-Oral Distalizing Device

The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. The anterior component of the inner bow is 3 mm free from the labial surface of anterior teeth

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female Patients with cervical vertebra maturation index (CVMI) 5 \& 6.
* From quarter unit to 3\\4-unit class II molar relationship.
* An overjet of an average 6mm.
* Full Set of permanent dentition except for the maxillary second molar.
* Favorable path of eruption for the maxillary third molar.

Exclusion Criteria

* Medically compromised Patients.
* Patients under long term medications.
* Patients having sever periodontal disease.
* CVMI 3 or less
* Full unit class II cases
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Hosam Abdullah Mohamed Zaza

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yehia Mostafa, Professr and Chairman

Role: STUDY_DIRECTOR

Future University in Egypt

Locations

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Future University In Egypt

New Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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FUE.REC(23)/11-2020

Identifier Type: -

Identifier Source: org_study_id

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