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

December 8, 2022 updated by: Nadeen Hafez, Future University in Egypt

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Future University in Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Procedure: 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
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
distalization amount of maxillary firs molars at the crown and root levels
Time Frame: From pre to post distalization (an average of 8 months)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of maxillary first molar Distalization
Time Frame: From pre- to post-distalization (an average of 8 months)
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)
From pre- to post-distalization (an average of 8 months)
Tipping of maxillary first molar
Time Frame: From pre- to post-distalization (an average of 8 months)
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).
From pre- to post-distalization (an average of 8 months)
Vertical position of maxillary first molar
Time Frame: From pre- to post-distalization (an average of 8 months)
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)
From pre- to post-distalization (an average of 8 months)
Inter molar width
Time Frame: From pre- to post-distalization (an average of 8 months)
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)
From pre- to post-distalization (an average of 8 months)
Molar rotation
Time Frame: From pre- to post-distalization (an average of 8 months)
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)
From pre- to post-distalization (an average of 8 months)
Tipping of maxillary second molar
Time Frame: From pre- to post-distalization (an average of 8 months)
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)
From pre- to post-distalization (an average of 8 months)
Tipping of maxillary third molar
Time Frame: From pre- to post-distalization (an average of 8 months)
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)
From pre- to post-distalization (an average of 8 months)
Vertical position of maxillary third molar
Time Frame: From pre- to post-distalization (an average of 8 months)

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)
From pre- to post-distalization (an average of 8 months)
Vertical position of upper incisors
Time Frame: From pre- to post-distalization (an average of 8 months)
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)
From pre- to post-distalization (an average of 8 months)
Anteroposterior position of upper incisors
Time Frame: From pre- to post-distalization (an average of 8 months)
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)
From pre- to post-distalization (an average of 8 months)
upper incisors torque
Time Frame: From pre- to post-distalization (an average of 8 months)
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)
From pre- to post-distalization (an average of 8 months)
Anteroposterior changes of upper first and second premolars
Time Frame: From pre- to post-distalization (an average of 8 months)
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)
From pre- to post-distalization (an average of 8 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Future University in Egypt

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yehya mostafa, Professor and chairman, Future University in Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUE.REC(14)/7-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected participant data (IPD)

IPD Sharing Time Frame

Data will be available after publication

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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