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

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

Study Overview

• Status: Unknown
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Procedure: computer guided surgical; Device: CBCT; Device: CBCT; Procedure: Conventional surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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; Device: CBCT; For measuring the bone removeal; Device: CBCT; for identifed the nerve
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	Device: CBCT; For measuring the bone removeal; Device: CBCT; for identifed the nerve; Procedure: Conventional surgery; Low speed motor with surgiacl round burs and surgical fissure for removal a covering bone with decapitation and guttering formation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .

Collaborators and Investigators

• Sponsor: Alaadden Mahmoud Abu Al Enein

Study record dates

Study Major Dates

• Study Start (Anticipated): March 28, 2018
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 30, 2018

Study Registration Dates

• First Submitted: February 10, 2018
• First Submitted That Met QC Criteria: February 25, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 25, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: 171986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No