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

Class II Malocclusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05647720
• Other study ID #: FUE.REC(14)/7-2019
• Status: Completed
• Phase: N/A
• Start date: February 28, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: December 2022
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 15, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class II Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Future University in Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	From pre- to post-distalization (an average of 8 months)
Secondary	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).	From pre- to post-distalization (an average of 8 months)
Secondary	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)	From pre- to post-distalization (an average of 8 months)
Secondary	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)	From pre- to post-distalization (an average of 8 months)
Secondary	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)	From pre- to post-distalization (an average of 8 months)
Secondary	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)	From pre- to post-distalization (an average of 8 months)
Secondary	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)	From pre- to post-distalization (an average of 8 months)
Secondary	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)	From pre- to post-distalization (an average of 8 months)
Secondary	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)	From pre- to post-distalization (an average of 8 months)
Secondary	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)	From pre- to post-distalization (an average of 8 months)
Secondary	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)	From pre- to post-distalization (an average of 8 months)
Secondary	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)	From pre- to post-distalization (an average of 8 months)