Clinical trial NCT05944939: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Impacted Third Molar Tooth
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 104
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Measure of bone density with help of cone beam computerized tomography after 3 months and 6 months
timeFrame: 3 month and 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow Dental college Dow university of health sciences
state: Sindh
city: Karachi
country: Pakistan
facility: Dow university of health sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: D O W
role: PRINCIPAL_INVESTIGATOR
References: