NCT06044766

Brief Summary

A clinical study will be conducted to verify the reliability of the root form classification of impacted lower third molars that was put by Abu-Mostafa N (2023) The root forms of partially or fully impacted lower third molars will be classified pre-operatively based on panoramic radiograph, then clinically after extraction, and the identified root classifications will be compared.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

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

First Submitted

Initial submission to the registry

May 11, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

May 11, 2023

Last Update Submit

September 17, 2023

Conditions

Keywords

impacted lower third olarsRoots morphologyRoot forms

Outcome Measures

Primary Outcomes (2)

  • Frequency of discrepancies and agreements on the classified root forms

    To report the radiographic classifications of root forms by two examiners

    Before surgical exatration

  • Frequency of discrepancies and agreements on the classified root forms

    To report the clinical classifications of root forms

    Immidiately after extraction

Secondary Outcomes (3)

  • The frequency of root types

    Immediately after extraction

  • The frquency of fused root forms

    Immediately after extraction

  • The frequency of separated root forms

    Immediately after extraction

Study Arms (1)

Surgical exatrction of impacted lower third molars

OTHER

Clinical intervention: Surgical exatrction of impacted lower third molar to examine and classify the roots, then to compare it with radiographic classification

Procedure: Surgical exatrction of impacted lower third molars

Interventions

Surgical exatrction of impacted lower third molars to verify the form of the root

Surgical exatrction of impacted lower third molars

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with impacted lower third molars who visit Riyadh Elm University" hospital and have lower third molars which are diagnosed clinically and radiographically as partially or fully impacted. The roots of these third molars have to be fully formed.

You may not qualify if:

  • incomplete apex formation and root resorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Nedal A Abu-Mostafa, Assistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

May 11, 2023

First Posted

September 21, 2023

Study Start

October 1, 2023

Primary Completion

July 31, 2024

Study Completion

August 15, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

After publication