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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03447067
Other study ID # 171986
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 10, 2018
Last updated February 25, 2018
Start date March 28, 2018
Est. completion date July 30, 2018

Study information

Verified date February 2018
Source Cairo University
Contact alaaedein M abu al einain, master
Phone 00201011618208
Email surgeonalaamahmoud@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 18
Est. completion date July 30, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
computer 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
Conventional surgery
Low speed motor with surgiacl round burs and surgical fissure for removal a covering bone with decapitation and guttering formation
Device:
CBCT
For measuring the bone removeal
CBCT
for identifed the nerve

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alaadden Mahmoud Abu Al Enein

Outcome

Type Measure Description Time frame Safety issue
Primary 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 . immediate post operative ,at three day pain change till fourteen day day .
Secondary 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. immediate post operative ,at three day inter incisal change till fourteen day .
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