Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-31 @ 4:08 PM
Study NCT ID:
NCT06044766
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verification of the Root Form Classification of Impacted Lower Third Molars
Sponsor:
Riyadh Colleges of Dentistry and Pharmacy
Organization:
Study Overview
Official Title:
A Clinical Study to Verify the Reliability of Root Form Classification of Impacted Lower Third Molars
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: