Assessment of Bone Density in Impacted Mandibular Third Molar

"Post" Operative Assessment of Socket Healing With Placement of Concentrated Growth Factor in Impacted Mandibular Third Molar Socket

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Procedure: Surgical extraction of impacted third molar

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

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Dow University of Health Sciences
    • Karachi, Sindh, Pakistan
      • Dow Dental college Dow university of health sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case group; After third molar extraction concentrated growth factor is palced in socket and closure with silk3.0 compare bone density with control group	Procedure: Surgical extraction of impacted third molar; After surgical extraction of mandibular impacted teeth concentrated growth factor placed in socket closure done with help of silk 3.0 suture
Experimental: Control group; After extraction closure with silk 3.0 compare bone density with cases	Procedure: Surgical extraction of impacted third molar; After surgical extraction of mandibular impacted teeth concentrated growth factor placed in socket closure done with help of silk 3.0 suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 month and 6 month

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: D O W, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Actual): June 6, 2022
• Study Completion (Estimated): December 6, 2023

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Randmised control trial
• IPD Sharing Time Frame: 6 month
• IPD Sharing Access Criteria: Bone density with cbct
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

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