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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
Riyadh Colleges of Dentistry and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 11, 2023
    Last Updated
    September 17, 2023
    Sponsor
    Riyadh Colleges of Dentistry and Pharmacy
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    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

    Learn more about this trial

    Verification of the Root Form Classification of Impacted Lower Third Molars

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