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

Primary Purpose

Class II Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Distalization combined with upper third molars extraction
Distalization without upper third molars extraction
Sponsored by
Future University in Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Malocclusion focused on measuring Infra-zygomatic mini-implant, Distalization, Infra-zygomatic crest, Digital models, molar tipping

Eligibility Criteria

16 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Future University in Egypt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Third molar extraction group

Third molar presence group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Rate of maxillary first molar Distalization
Incremental changes in the antero-posterior position of maxillary first molars assessed on digitized models taken for each patient before and after distalization and in each follow up visit. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)
Tipping of maxillary first molar
Angular changes of maxillary first molar assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes(measurement of the angles in degrees).
Vertical position of maxillary first molar
vertical positional changes of maxillary first molar assessed on 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)
Inter molar width
Changes in the transvers distance between the right and left upper first molars assessed on digitized models taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)
Molar rotation
Study models that are taken pre and post retraction (then digitalized) will be used to assess the rotation of the maxillary first molars in relation to a reference line (measurement of the angles in degrees)
Tipping of maxillary second molar
Angular changes of maxillary second molar assessed on 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 of in degrees)
Tipping of maxillary third molar
Angular changes of maxillary third molar assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measurement of the angles in degrees)
Vertical position of maxillary third molar
Vertical positional changes of maxillary third molar assessed on cone beam computed (measured in mm)tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks , reference lines, and planes (measured in mm)
Vertical position of upper incisors
Vertical positional changes of upper incisors assessed on 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)
Anteroposterior position of upper incisors
Antero-posterior change in the anteroposterior position of upper incisors assessed on 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)
upper incisors torque
Angular changes of upper incisors assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measurement of the angles in degrees)
Anteroposterior changes of upper first and second premolars
Antero-posterior change in the position of maxillary first and second premolars assessed on digitized models taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)

Full Information

First Posted
November 25, 2022
Last Updated
December 8, 2022
Sponsor
Future University in Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05647720
Brief Title
Effect of Maxillary Third Molar Extraction vs. Non-extraction on Distalization of First Molars in a Group of Adolescent Patients
Official Title
Effect of Maxillary Third Molar Extraction vs Non-extraction on Distalization of First Molars in a Group of Adolescent Patients Using Infra-Zygomatic Gear Distalizer: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
January 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future University in Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion
Keywords
Infra-zygomatic mini-implant, Distalization, Infra-zygomatic crest, Digital models, molar tipping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Third molar extraction group
Arm Type
Experimental
Arm Description
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.
Arm Title
Third molar presence group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Distalization combined with upper third molars extraction
Intervention Description
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
Intervention Name(s)
Distalization without upper third molars extraction
Intervention Description
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
Primary Outcome Measure Information:
Title
distalization amount of maxillary firs molars at the crown and root levels
Description
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)
Time Frame
From pre to post distalization (an average of 8 months)
Secondary Outcome Measure Information:
Title
Rate of maxillary first molar Distalization
Description
Incremental changes in the antero-posterior position of maxillary first molars assessed on digitized models taken for each patient before and after distalization and in each follow up visit. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)
Time Frame
From pre- to post-distalization (an average of 8 months)
Title
Tipping of maxillary first molar
Description
Angular changes of maxillary first molar assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes(measurement of the angles in degrees).
Time Frame
From pre- to post-distalization (an average of 8 months)
Title
Vertical position of maxillary first molar
Description
vertical positional changes of maxillary first molar assessed on 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)
Time Frame
From pre- to post-distalization (an average of 8 months)
Title
Inter molar width
Description
Changes in the transvers distance between the right and left upper first molars assessed on digitized models taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)
Time Frame
From pre- to post-distalization (an average of 8 months)
Title
Molar rotation
Description
Study models that are taken pre and post retraction (then digitalized) will be used to assess the rotation of the maxillary first molars in relation to a reference line (measurement of the angles in degrees)
Time Frame
From pre- to post-distalization (an average of 8 months)
Title
Tipping of maxillary second molar
Description
Angular changes of maxillary second molar assessed on 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 of in degrees)
Time Frame
From pre- to post-distalization (an average of 8 months)
Title
Tipping of maxillary third molar
Description
Angular changes of maxillary third molar assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measurement of the angles in degrees)
Time Frame
From pre- to post-distalization (an average of 8 months)
Title
Vertical position of maxillary third molar
Description
Vertical positional changes of maxillary third molar assessed on cone beam computed (measured in mm)tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks , reference lines, and planes (measured in mm)
Time Frame
From pre- to post-distalization (an average of 8 months)
Title
Vertical position of upper incisors
Description
Vertical positional changes of upper incisors assessed on 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)
Time Frame
From pre- to post-distalization (an average of 8 months)
Title
Anteroposterior position of upper incisors
Description
Antero-posterior change in the anteroposterior position of upper incisors assessed on 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)
Time Frame
From pre- to post-distalization (an average of 8 months)
Title
upper incisors torque
Description
Angular changes of upper incisors assessed on cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measurement of the angles in degrees)
Time Frame
From pre- to post-distalization (an average of 8 months)
Title
Anteroposterior changes of upper first and second premolars
Description
Antero-posterior change in the position of maxillary first and second premolars assessed on digitized models taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes (measured in mm)
Time Frame
From pre- to post-distalization (an average of 8 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehya Mostafa, Professor and Chairman
Organizational Affiliation
Future University in Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Future University in Egypt
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected participant data (IPD)
IPD Sharing Time Frame
Data will be available after publication

Learn more about this trial

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

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