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Assessment of Bone Density in Impacted Mandibular Third Molar

Primary Purpose

Impacted Third Molar Tooth

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Surgical extraction of impacted third molar
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth

Eligibility Criteria

17 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Both genders Age above 17 years Impacted mandibular third molar Exclusion Criteria: Teeth require closed extraction Significant medical history ( e.g. uncontrolled diabetes mellitus ) Patients with history of radiotherapy and chemotherapy Bleeding disorders Any pathology like tumor and cyst 6. Developmental disorder 7. Previously operated any surgery of jaw 8. cigarette smokers 9. Maxillary third molar

Sites / Locations

  • Dow Dental college Dow university of health sciences
  • Dow university of health sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Case group

Control group

Arm Description

After third molar extraction concentrated growth factor is palced in socket and closure with silk3.0 compare bone density with control group

After extraction closure with silk 3.0 compare bone density with cases

Outcomes

Primary Outcome Measures

Measure of bone density with help of cone beam computerized tomography after 3 months and 6 months
Cases compare with control with help of cone beam computerized tomography

Secondary Outcome Measures

Full Information

First Posted
May 30, 2023
Last Updated
August 1, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05944939
Brief Title
Assessment of Bone Density in Impacted Mandibular Third Molar
Official Title
"Post" Operative Assessment of Socket Healing With Placement of Concentrated Growth Factor in Impacted Mandibular Third Molar Socket
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
June 6, 2022 (Actual)
Study Completion Date
December 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dow University of Health Sciences

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
Preoperative radiograph will be taken to assess the type of impaction either mesioangular, horizontal, distoangular and check mouth opening. Two groups involve in my study. After taking consent from all patients in first group is control group open extraction of impacted mandibular third molar prepared concentrated growth factor placed in fresh socket closure done with silk 3.0. In second case group open extraction of impacted mandibular third molar is closure with silk 3.0 without placement of concentrated growth factor. Bone density will assessed using cone beam computed tomography 3 month and 6month postoperatively.
Detailed Description
Total number of patients who will fulfill the inclusion criteria of the study will be included in the study from oral and maxillofacial surgery OPD of Dow University of health sciences dow dental college campus. Preoperative radiograph will be taken to assess the type of impaction either mesioangular, horizontal, distoangular and check mouth opening. Two groups involve in my study. After taking consent from all patients in first group is control group open extraction of impacted mandibular third molar prepared concentrated growth factor placed in fresh socket closure done with silk 3.0. In second case group open extraction of impacted mandibular third molar is closure with silk 3.0 without placement of concentrated growth factor. CONCENTRATED GROWTH FACTOR PREPARATION: Concentrated growth factor is prepared by using patients own venous blood 10ml drawn from patients radial forearm which placed in without anticoagulant solutions in a sterile vacuette tubes. Centrifuged 30 sec acceleration, 2 mint -2700rmp, 4mint 2400rmp, 4 mints -2700rmp,3 mints -3000rmp, 30 sec deceleration and stop. Concentrated growth factor contain rich growth factor taken from tube with help of tweezer with cutting two phases with scissors where the center and bottom layers connected. When concentrated growth factor is separated a quantity of growth factors is present at interface between concentrated growth factor and erythrocyte layer. concentrated growth factor glue is mould and squeezed the liquid element, to obtain a concentrated growth factor membrane and that membrane will be stored in normal saline for future. In second case group. After open extraction of impacted mandibular third molar fresh socket closure will be performed with silk 3.0. Same Postoperative instruction and medication will be given to all patients. Bone density will assessed using cone beam computed tomography 3 month and 6month postoperatively. Comparision between mesioangular with mesioangular, distoangular with distoangular, horizontal with horizontal , vertical with vertical.(11)The mean gray level histogram values of the cone beam computed tomography at extraction socket will be obtained through digora software , gray scale is a digital photograpy , computer generated imagery and colorimetry . For each defect a regions of intrest can be created for the defect region and one the surrounding bone using the freehand selection tool, the minimum safety distance from one pixel to any cortical structure has to be ensured,after creating region of intrest the analysis is performed and result is transferred directly to statical analysis sheet,(Geiger, Blem et al. 2016) The difference in mean grey level values at study and control sites were tabulated and compared bone density. The purpose of using mandibular third molar because third molar is most commonly impacted teeth and routinly extracted with number of complications being reported and overcome these complication we are using CGF in third molar socket

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
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case group
Arm Type
Experimental
Arm Description
After third molar extraction concentrated growth factor is palced in socket and closure with silk3.0 compare bone density with control group
Arm Title
Control group
Arm Type
Experimental
Arm Description
After extraction closure with silk 3.0 compare bone density with cases
Intervention Type
Procedure
Intervention Name(s)
Surgical extraction of impacted third molar
Intervention Description
After surgical extraction of mandibular impacted teeth concentrated growth factor placed in socket closure done with help of silk 3.0 suture
Primary Outcome Measure Information:
Title
Measure of bone density with help of cone beam computerized tomography after 3 months and 6 months
Description
Cases compare with control with help of cone beam computerized tomography
Time Frame
3 month and 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both genders Age above 17 years Impacted mandibular third molar Exclusion Criteria: Teeth require closed extraction Significant medical history ( e.g. uncontrolled diabetes mellitus ) Patients with history of radiotherapy and chemotherapy Bleeding disorders Any pathology like tumor and cyst 6. Developmental disorder 7. Previously operated any surgery of jaw 8. cigarette smokers 9. Maxillary third molar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D O W
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow Dental college Dow university of health sciences
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Dow university of health sciences
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Randmised control trial
IPD Sharing Time Frame
6 month
IPD Sharing Access Criteria
Bone density with cbct

Learn more about this trial

Assessment of Bone Density in Impacted Mandibular Third Molar

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