CClinicalTrials.gg
Status unknownNCT03447067Updated Feb 27, 2018

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

An interventional study of computer guided surgical and Conventional surgery in Impacted Third Molar Tooth, sponsored by Alaadden Mahmoud Abu Al Enein. Status unknown. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by Alaadden Mahmoud Abu Al Enein · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

in patent have deeply impacted lower third molar ,dose computer guided enhance surgical outcome versus conventional surgical remove of wisdom teeth

Read the 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.
02

Conditions studied

  • Impacted Third Molar Tooth

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03

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    Conventional surgery

    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)

    Procedure: computer guided surgical · Device: CBCT

  • Experimental
    computer guided surgery

    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

    Procedure: Conventional surgery · Device: CBCT

Interventions

  • Procedurecomputer guided surgical

    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

  • ProcedureConventional surgery

    Low speed motor with surgiacl round burs and surgical fissure for removal a covering bone with decapitation and guttering formation

  • DeviceCBCT

    For measuring the bone removeal

  • DeviceCBCT

    for identifed the nerve

05

What researchers measure

Primary outcomes

  1. 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 .

    Time frame: immediate post operative ,at three day pain change till fourteen day day .

Secondary outcomes

  1. 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.

    Time frame: immediate post operative ,at three day inter incisal change till fourteen day .

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03447067
Lead sponsor
Alaadden Mahmoud Abu Al Enein
Responsible party
Alaadden Mahmoud Abu Al Enein (Principal Investigator, Cairo University) — Sponsor-investigator
First posted
Feb 27, 2018
Start date
Mar 28, 2018 (estimated)
Primary completion
Jul 1, 2018 (estimated)
Completion
Jul 30, 2018 (estimated)
Last update
Feb 27, 2018

Study contacts

alaaedein M abu al einain, master
Contact
surgeonalaamahmoud@gmail.com
00201011618208
Mamdouh S Sayed Ahmed, Professor
Contact
dr.mamdouhahmed@hotmail.com
00201222173262

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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