NCT04857658

Brief Summary

What is the effect of extraction orthodontic treatment in comparison to non- extraction treatment on the position, inclination and incidence of impaction of the third molars?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 4, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

2.2 years

First QC Date

April 20, 2021

Last Update Submit

September 5, 2023

Conditions

Keywords

third molar impaction, third molar angulation, third molar vertical position

Outcome Measures

Primary Outcomes (1)

  • third molar angulation

    The angulation of the mandibular third molars

    at the end of orthodontic treatment

Secondary Outcomes (4)

  • space available for the upper and lower third molar

    at the end of orthodontic treatment

  • Angulation of the third molar.

    at the end of orthodontic treatment

  • The vertical position of the third molars

    at the end of orthodontic treatment

  • the mineralization status of the third molars

    at the end of orthodontic treatment

Study Arms (2)

extraction treatment

ACTIVE COMPARATOR

patients will be referred for extraction of the upper and lower first premolars to relieve the crowding.

Procedure: extraction orthodontic treatment plan

non-extraction treatment

NO INTERVENTION

Leveling and alignment of the moderate crowding will be performed through a recall visits of 4 weeks for wire activation. inter-proximal reduction step might be done if needed.

Interventions

patients will be referred for extraction of the upper and lower first premolars then orthodontic treatment will follow.

extraction treatment

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescent males and females (14-18 years) with Bilaterally unerupted developing third molars. Not more than two thirds of the root development of the third molars had taken place.
  • Dental Class I malocclusion cases requiring four premolar extraction with a moderate anchorage requirement.
  • low or increased vertical dimension.

You may not qualify if:

  • Premolar extraction cases requiring maximum anchorage preparation.
  • Low vertical dimension.
  • patients without dentofacial deformities, severe facial asymmetries, or missing teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Aboalnaga

Cairo, 12588, Egypt

Location

Study Officials

  • amira aboalnaga

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
amira ahmed aboalnaga

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 23, 2021

Study Start

January 4, 2021

Primary Completion

March 4, 2023

Study Completion

December 10, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

the pre-treatment and post-treatment records

Locations