Verification of the Root Form Classification of Impacted Lower Third Molars

NCT ID: NCT06044766

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

According to Abu-Mostafa N, the roots of impacted lower third molars are classified into two types: Fused roots and separated roots. Both have different forms:

Fused roots forms: Straight, Curved distal, Curved mesial, and S-shaped.

Separated roots forms: Straight, Both roots are curved distal, Both roots are curved mesial, Joined roots, One root is straight and one is curved, and More than two roots.

A panoramic radiograph will be taken before extraction, then the roots will be classified by two Oral biologist and Oral and Maxillofacial Surgeon individually. After surgical extraction of the third molar, the roots will be examined clinically and classified according to the same classification.

The two pre-extraction radiographic classifications will be compared together, and then they will be compared with the clinical classification to check if there is a discrepancy.

The surgical extraction procedure:

Local anesthesia will be achieved by inferior alveolar nerve block and buccal infiltration using Lidocaine 2% with Epinephrine 1:100,000. A flap with a distobuccal releasing incision will be done. The bone reduction will be performed by a low-speed surgical handpiece under irrigation with normal saline. Root separation is done of required for the third molars with separated root forms. The tooth will be luxated by straight elevators and then extracted.

The evaluation results will be categorized to:

* Agreement: The two pre-extraction radiographic evaluations and the clinical evaluations are similar
* Discrepancy 1: One pre-extraction radiographic evaluation and the clinical evaluations are similar, but the other radiographic evaluation differs.
* Discrepancy 2: the two pre-extraction radiographic evaluations are similar, but the clinical evaluation differs.
* Disagreement: The three evaluations are different

The results will be analyzed regarding frequencies and association of each category with root forms

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Impacted Lower Third Molars Roots

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgical exatrction of impacted lower third molars

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

Group Type OTHER

Surgical exatrction of impacted lower third molars

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgical exatrction of impacted lower third molars

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Exclusion Criteria

incomplete apex formation and root resorption
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nedal Abu-Mostafa

Assistant Professor in Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nedal A Abu-Mostafa, Assistant Professor

Role: CONTACT

+966506275782

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REU2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pulp Inflammatory Markers and Outcome of Pulpotomy
NCT06960603 ENROLLING_BY_INVITATION NA