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

NCT05647720 | Completed

• 1 other identifier: FUE.REC(14)/7-2019
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Class II Malocclusion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• distalization amount of maxillary firs molars at the crown and root levels

  Anteroposterior changes in the position of maxillary first molars assessed on digitized models and cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes(measured in mm)

  From pre to post distalization (an average of 8 months)

Secondary Outcomes (12)

• Rate of maxillary first molar Distalization

  From pre- to post-distalization (an average of 8 months)

• Tipping of maxillary first molar

  From pre- to post-distalization (an average of 8 months)

• Vertical position of maxillary first molar

  From pre- to post-distalization (an average of 8 months)

• Inter molar width

  From pre- to post-distalization (an average of 8 months)

• Molar rotation

  From pre- to post-distalization (an average of 8 months)

Study Arms (2)

Third molar extraction group

EXPERIMENTAL

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.

Procedure: Distalization combined with upper third molars extraction

Third molar presence group

EXPERIMENTAL

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.

Procedure: Distalization without upper third molars extraction

Interventions

Distalization combined with upper third molars extraction 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 extraction group

Distalization without upper third molars extraction 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

Third molar presence group

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• skeletal Class II or Class III relationship.
• past orthodontic treatment.
• poor oral hygiene.
• Increased vertical dimension.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

Cairo, Egypt

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Yehya Mostafa, Professor and Chairman

  Future University in Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 12, 2022
• Study Start: February 28, 2021
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after publication

Locations

EG (1)