Verification of the Root Form Classification of Impacted Lower Third Molars

A Clinical Study to Verify the Reliability of Root Form Classification of Impacted Lower Third Molars

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Impacted Lower Third Molars Roots
• Intervention / Treatment: Procedure: Surgical exatrction of impacted lower third molars

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nedal A Abu-Mostafa, Assistant Professor; Phone Number: +966506275782; Email: nabumostafa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Procedure: Surgical exatrction of impacted lower third molars; Surgical exatrction of impacted lower third molars to verify the form of the root

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of root types	The frequency of fused roots and separated roots	Immediately after extraction
The frquency of fused root forms	The frequency of the four fused roots forms	Immediately after extraction
The frequency of separated root forms	The frequency of the six separated root forms	Immediately after extraction

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: September 17, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 17, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: impacted lower third olars; Roots morphology; Root forms
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: REU2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No