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

Not Applicable

Completed

• Conditions: Class II Malocclusion
• Interventions: Procedure: Distalization without upper third molars extraction; Procedure: Distalization combined with upper third molars extraction

• Registration Number: NCT05647720
• Lead Sponsor: Future University in Egypt

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.

Study Timeline

• Study Start: 2021-02-28
• Primary Completion: 2022-01-15
• Study Completion: 2022-01-15
• Study First Submitted: 2022-11-25
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-08
• Last Update Submitted: 2022-12-08
• Study First Posted: 2022-12-12
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Third molar presence group	Distalization without upper third molars extraction	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.
Third molar extraction group	Distalization combined with upper third molars extraction	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.

Primary Outcome Measures

Name	Time	Method
distalization amount of maxillary firs molars at the crown and root levels	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)

Secondary Outcome Measures

Name	Time	Method
Vertical position of maxillary first molar	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)
Molar rotation	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)
Vertical position of maxillary third molar	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)
Tipping of maxillary first molar	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).
Vertical position of upper incisors	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)
Inter molar width	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)
Tipping of maxillary third molar	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)
Anteroposterior position of upper incisors	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)
Rate of maxillary first molar Distalization	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)
Tipping of maxillary second molar	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)
upper incisors torque	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)
Anteroposterior changes of upper first and second premolars	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)

Trial Locations

Locations (1)

Future University in Egypt; 🇪🇬 Cairo, Egypt