NCT06098885

Brief Summary

What is the effect of the different treatment modalities (distalization versus upper premolar extraction) of class II malocclusion on the position, inclination and incidence of impaction of the upper third molars?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

September 8, 2021

Last Update Submit

October 22, 2023

Conditions

Keywords

distalizationpremolar extractionupper third molarimpaction of third molar

Outcome Measures

Primary Outcomes (1)

  • The angulation of the maxillary third molars.

    the angle between the long axis of the third molar and the palatal plane

    up to 24 weeks.

Secondary Outcomes (2)

  • The vertical position of the third molars

    up to 24 weeks

  • The mineralization status of the third molars

    up to 24 weeks

Study Arms (2)

extraction treatment

patients treated with bilateral upper first premolar extraction orthodontic treatment with moderate anchorage.

Other: extraction orthodontic treatment

distalization treatment

patients treated by distalization orthodontic treatment.

Interventions

bilateral upper first premolar extraction orthodontic treatment with moderate anchorage.

extraction treatment

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

• Egyptian Adolescent males and females (16 -18 years)

You may qualify if:

  • Adolescent males and females (16 -18 years) with Bilaterally developing maxillary third molars. Not more than two thirds of the root development of the third molars had taken place.
  • Class II malocclusion cases that were treated by 1) maxillary premolar extraction with a moderate anchorage requirement and achieved full unit class II molar relationship or 2) Distalization treatment plan and class I molar relationship was achieved.
  • Patients with high-quality pre- and post-treatment radiographs.
  • Normal or increased vertical dimension.

You may not qualify if:

  • Maxillary Premolar extraction cases requiring maximum anchorage preparation.
  • Low vertical dimension.
  • Patients without dentofacial deformities, severe facial asymmetries, microdontia or hypodontia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Aboalnaga

Cairo, 12588, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 8, 2021

First Posted

October 25, 2023

Study Start

September 4, 2021

Primary Completion

June 4, 2023

Study Completion

June 4, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations