Effect of Maxillary Third Molar Extraction vs. Non-extraction on Distalization of First Molars in a Group of Adolescent Patients

NCT ID: NCT05647720

Last Updated: 2022-12-12

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2022-01-15

Brief Summary

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There is a scarcity in literature regarding the influence of maxillary third molar on distalization . This study aimed to compare the influence of unerupted maxillary third molars and their extraction on the bilateral distalization of upper first molars using the infra-zygomatic gear distalizer

Detailed Description

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Maxillary molar distalization is one of the non-extraction modalities for treating class II malocclusion. When distalizing maxillary molars In adults, it is not a problem to extract fully erupted third molars, and it may even be suggested that the extraction site may accommodate distalization. On the contrary, adolescents usually have unerupted third molars with partially formed roots, rendering the surgical extraction more difficult and traumatic. The necessity of surgically extracting upper third molar buds before distalization remains questionable. Therefore, this study was conducted to three-dimensionally assess the impact of maxillary third molar presence on distalizing maxillary molars in adolescent patients having Class II malocclusion.

Conditions

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Class II Malocclusion

Keywords

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Infra-zygomatic mini-implant Distalization Infra-zygomatic crest Digital models molar tipping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Only the outcome assessors will be blind. The patients name will be sealed from the pre- and post-radiographs and study models. Then two assessors will carry out, blindly and independently, the measurements and analysis of the study

Study Groups

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Third molar extraction group

After surgical extraction of unerupted upper third molars, the maxillary first molars were distalized using the infra-zygomatic gear distalizer, which is anchored to infra-zygomatic mini-implants inserted in the infra-zygomatic crest.

Group Type EXPERIMENTAL

Distalization combined with upper third molars extraction

Intervention Type PROCEDURE

After surgical extraction of unerupted upper third molars, the maxillary first molars were distalized using a labial bow with two soldered crimpable hooks distal to the upper lateral incisors. The labial bow fitted in the flying tube of the upper first molar bands. It was anchored bilaterally to the infra-zygomatic mini-implant by closed coil spring that applied a force of 300gm on each side

Third molar presence group

Without extraction of unerupted upper third molars, the maxillary first molars were distalized using the infra-zygomatic gear distalizer, which is anchored to infra-zygomatic mini-implants inserted in the infra-zygomatic crest.

Group Type EXPERIMENTAL

Distalization without upper third molars extraction

Intervention Type PROCEDURE

The maxillary first molars were distalized , without extracting upper third molars, using a labial bow with two soldered crimpable hooks distal to the upper lateral incisors. The labial bow fitted in the flying tube of the upper first molar bands. It was anchored bilaterally to the infra-zygomatic mini-implant by closed coil spring that applied a force of 300gm on each side

Interventions

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Distalization combined with upper third molars extraction

After surgical extraction of unerupted upper third molars, the maxillary first molars were distalized using a labial bow with two soldered crimpable hooks distal to the upper lateral incisors. The labial bow fitted in the flying tube of the upper first molar bands. It was anchored bilaterally to the infra-zygomatic mini-implant by closed coil spring that applied a force of 300gm on each side

Intervention Type PROCEDURE

Distalization without upper third molars extraction

The maxillary first molars were distalized , without extracting upper third molars, using a labial bow with two soldered crimpable hooks distal to the upper lateral incisors. The labial bow fitted in the flying tube of the upper first molar bands. It was anchored bilaterally to the infra-zygomatic mini-implant by closed coil spring that applied a force of 300gm on each side

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adolescent patients aged 16-19 years
* skeletal Class I
* bilateral Class II molar relationship. defined by at least an end-to-end molar relationship.
* normal vertical growth pattern.
* full permanent dentition with unerupted upper third molars.

Exclusion Criteria

* skeletal Class II or Class III relationship.
* past orthodontic treatment.
* poor oral hygiene.
* Increased vertical dimension.
Minimum Eligible Age

16 Years

Maximum Eligible Age

19 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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Nadeen Hafez

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yehya Mostafa, Professor and Chairman

Role: STUDY_DIRECTOR

Future University in Egypt

Locations

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Future University in Egypt

Cairo, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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FUE.REC(14)/7-2019

Identifier Type: -

Identifier Source: org_study_id