Verification of the Root Form Classification of Impacted Lower Third Molars
Primary Purpose
Impacted Lower Third Molars Roots
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgical exatrction of impacted lower third molars
Sponsored by
About this trial
This is an interventional other trial for Impacted Lower Third Molars Roots focused on measuring impacted lower third olars, Roots morphology, Root forms
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Surgical exatrction of impacted lower third molars
Arm Description
Clinical intervention: Surgical exatrction of impacted lower third molar to examine and classify the roots, then to compare it with radiographic classification
Outcomes
Primary Outcome Measures
Frequency of discrepancies and agreements on the classified root forms
To report the radiographic classifications of root forms by two examiners
Frequency of discrepancies and agreements on the classified root forms
To report the clinical classifications of root forms
Secondary Outcome Measures
The frequency of root types
The frequency of fused roots and separated roots
The frquency of fused root forms
The frequency of the four fused roots forms
The frequency of separated root forms
The frequency of the six separated root forms
Full Information
NCT ID
NCT06044766
First Posted
May 11, 2023
Last Updated
September 17, 2023
Sponsor
Riyadh Colleges of Dentistry and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT06044766
Brief Title
Verification of the Root Form Classification of Impacted Lower Third Molars
Official Title
A Clinical Study to Verify the Reliability of Root Form Classification of Impacted Lower Third Molars
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Colleges of Dentistry and Pharmacy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Lower Third Molars Roots
Keywords
impacted lower third olars, Roots morphology, Root forms
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical exatrction of impacted lower third molars
Arm Type
Other
Arm Description
Clinical intervention: Surgical exatrction of impacted lower third molar to examine and classify the roots, then to compare it with radiographic classification
Intervention Type
Procedure
Intervention Name(s)
Surgical exatrction of impacted lower third molars
Intervention Description
Surgical exatrction of impacted lower third molars to verify the form of the root
Primary Outcome Measure Information:
Title
Frequency of discrepancies and agreements on the classified root forms
Description
To report the radiographic classifications of root forms by two examiners
Time Frame
Before surgical exatration
Title
Frequency of discrepancies and agreements on the classified root forms
Description
To report the clinical classifications of root forms
Time Frame
Immidiately after extraction
Secondary Outcome Measure Information:
Title
The frequency of root types
Description
The frequency of fused roots and separated roots
Time Frame
Immediately after extraction
Title
The frquency of fused root forms
Description
The frequency of the four fused roots forms
Time Frame
Immediately after extraction
Title
The frequency of separated root forms
Description
The frequency of the six separated root forms
Time Frame
Immediately after extraction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nedal A Abu-Mostafa, Assistant Professor
Phone
+966506275782
Email
nabumostafa@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
After publication
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Verification of the Root Form Classification of Impacted Lower Third Molars
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