NCT03447067

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

February 10, 2018

Last Update Submit

February 25, 2018

Conditions

Outcome Measures

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 .

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

Secondary Outcomes (1)

  • evaluation of maximum inter incisal opening

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

Study Arms (2)

Conventional surgery

EXPERIMENTAL

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 surgicalDevice: CBCT

computer guided surgery

EXPERIMENTAL

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 surgeryDevice: CBCT

Interventions

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

computer guided surgery
CBCTDEVICE

For measuring the bone removeal

Conventional surgery

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

alaaedein M abu al einain, master

CONTACT

Mamdouh S Sayed Ahmed, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2018

First Posted

February 27, 2018

Study Start

March 28, 2018

Primary Completion

July 1, 2018

Study Completion

July 30, 2018

Last Updated

February 27, 2018

Record last verified: 2018-02