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Computer Guided Versus Conventional Surgical Removal of Deeply Impacted Mandibular Third Molar With Preservation of External Oblique Ridge

Primary Purpose

Impacted Third Molar Tooth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
computer guided surgical
Conventional surgery
CBCT
CBCT
Sponsored by
Alaadden Mahmoud Abu Al Enein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient with deeply impacted mandibular third molar
  • patients should be free from any systematic disease that affect normal healing

Exclusion Criteria:

  • -Patient with soft tissue impaction and impaction class A position 1
  • Medical problem that may interfere with the procedures such as bleeding disorder & pregnant.
  • Uncooperative patient.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Conventional surgery

    computer guided surgery

    Arm Description

    comprised 9 patient undergoing surgical removal of deeply impacted mandibular third molar by regular manor. (Based on :Panorama and CBCT ) technique : 1- flap design 2- bone removal 3- tooth division 4- closure flap (suture)

    comprised 9 patient undergoing surgical removal of deeply impacted mandibular third molar using computer guided surgical cutting stent. Based on (panorama , CBCT and fabricating computer guided stent technique: 1- flap design 2- accurate setting stent in a predesign site 3- bony window removing according to the stent design 4- surgical separation of the teeth with extraction the remaning part . 5- identify the nerve 6- replace the bony window in to original place with stability 7- closure and depridment

    Outcomes

    Primary Outcome Measures

    Pain
    each patient well be asked to rate current and worst pain intensity on visual analogue scale (VAS ) of 0-10 with Zero being no pain and Ten corresponds to the worst pain(pain change during follow up period .

    Secondary Outcome Measures

    evaluation of maximum inter incisal opening
    assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisor by using tape graduated method.

    Full Information

    First Posted
    February 10, 2018
    Last Updated
    February 25, 2018
    Sponsor
    Alaadden Mahmoud Abu Al Enein
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03447067
    Brief Title
    Computer Guided Versus Conventional Surgical Removal of Deeply Impacted Mandibular Third Molar With Preservation of External Oblique Ridge
    Official Title
    Computer Guided Versus Conventional Surgical Removal of Deeply Impacted Mandibular Third Molar With Preservation of External Oblique Ridge
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 28, 2018 (Anticipated)
    Primary Completion Date
    July 1, 2018 (Anticipated)
    Study Completion Date
    July 30, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Alaadden Mahmoud Abu Al Enein

    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
    in patent have deeply impacted lower third molar ,dose computer guided enhance surgical outcome versus conventional surgical remove of wisdom teeth
    Detailed Description
    P- Patient with deeply impacted mandibular molar I- Computer guided surgical cutting stent C- Conventional extraction O- Clinical outcome sound radiographic outcomes primary outcome - pain : each patient well be asked to rate current and worst pain intensity on visual analogue scale (VAS ) of 0-10 with Zero being no pain and Ten corresponds to the worst pain. Secondary outcome evaluation of maximum inter incisal opening: assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisor by using tape graduated method. evaluation of edema throw use nylon thread.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Impacted Third Molar Tooth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional surgery
    Arm Type
    Experimental
    Arm Description
    comprised 9 patient undergoing surgical removal of deeply impacted mandibular third molar by regular manor. (Based on :Panorama and CBCT ) technique : 1- flap design 2- bone removal 3- tooth division 4- closure flap (suture)
    Arm Title
    computer guided surgery
    Arm Type
    Experimental
    Arm Description
    comprised 9 patient undergoing surgical removal of deeply impacted mandibular third molar using computer guided surgical cutting stent. Based on (panorama , CBCT and fabricating computer guided stent technique: 1- flap design 2- accurate setting stent in a predesign site 3- bony window removing according to the stent design 4- surgical separation of the teeth with extraction the remaning part . 5- identify the nerve 6- replace the bony window in to original place with stability 7- closure and depridment
    Intervention Type
    Procedure
    Intervention Name(s)
    computer guided surgical
    Intervention Description
    has three cutting guided plane for identify the position of place of the third molar, it have beveled cut for stability after remove the teeth and placing the bony window
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional surgery
    Intervention Description
    Low speed motor with surgiacl round burs and surgical fissure for removal a covering bone with decapitation and guttering formation
    Intervention Type
    Device
    Intervention Name(s)
    CBCT
    Intervention Description
    For measuring the bone removeal
    Intervention Type
    Device
    Intervention Name(s)
    CBCT
    Intervention Description
    for identifed the nerve
    Primary Outcome Measure Information:
    Title
    Pain
    Description
    each patient well be asked to rate current and worst pain intensity on visual analogue scale (VAS ) of 0-10 with Zero being no pain and Ten corresponds to the worst pain(pain change during follow up period .
    Time Frame
    immediate post operative ,at three day pain change till fourteen day day .
    Secondary Outcome Measure Information:
    Title
    evaluation of maximum inter incisal opening
    Description
    assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisor by using tape graduated method.
    Time Frame
    immediate post operative ,at three day inter incisal change till fourteen day .

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient with deeply impacted mandibular third molar patients should be free from any systematic disease that affect normal healing Exclusion Criteria: -Patient with soft tissue impaction and impaction class A position 1 Medical problem that may interfere with the procedures such as bleeding disorder & pregnant. Uncooperative patient.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    alaaedein M abu al einain, master
    Phone
    00201011618208
    Email
    surgeonalaamahmoud@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mamdouh S Sayed Ahmed, Professor
    Phone
    00201222173262
    Email
    dr.mamdouhahmed@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Computer Guided Versus Conventional Surgical Removal of Deeply Impacted Mandibular Third Molar With Preservation of External Oblique Ridge

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