Investigation of the Effects of CGF and A-PRF on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery

Study Overview
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Brief Summary
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The objective of this case-control intervention study is to explore the effectiveness of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery

Detailed Description
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In the present study, 75 patient, whose ages ranged between 18-30 and have an impacted lower third molar which is in vertical or mesiyoangular position and has class I and II ramus relationship and class B and C depth, will included. 75 patient will divided randomly into three groups as CGF, A-PRF and Control. After third molar surgery CGF and A-PRF will prepared and applied to the extraction sockets in CGF and A-PRF groups. nothing will applied to the control group. Post operative pain, edema and trismus will measured at 2nd and 7th days.

Official Title
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Clinical Investigation of the Effects of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery

Conditions
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Trismus, Edema, Pain, Post-Op Complication

Intervention / Treatment
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* Other: Concentrated Growth Factor (CGF)
* Other: Advanced Platelet Rich Fibrin (A-PRF)
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting asymptomatic impacted lower third molar tooth in the vertical or mesioanguler position according to the Winter classification, Class I and II ramus relation and class B and C depth according to Pell-Gregory classification Patients between the ages of 18-30, Non-smokers, Patients with ASA I status Exclusion Criteria: Who does not want to be volunteer for the study, Do not comply with post-operative recommendations, Operation lasting more than 30 minutes, During pregnancy or lactation, Have a chronic systemic disorder that may affect healing. Unable to cooperate, Post-operative infection, Patients with pericoronitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Concentrated Growth Factor (CGF)<br>Participants with impacted lower third molar | Other: Concentrated Growth Factor (CGF)<br>* CGF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for CGF)<br>|
| Active Comparator: Advanced Platelet Rich Fibrin (A-PRF)<br>Participants with impacted lower third molar | Other: Advanced Platelet Rich Fibrin (A-PRF)<br>* A-PRF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for A-PRF)<br>|
| Sham Comparator: Control<br>Participants with impacted lower third molar | Other: Control<br>* Nothing applied after extraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edema-amount change of swelling | In order to evaluate the amount change of swelling after the operation, horizontal and vertical measurements will be made from 5 reference points including tragus, lip corner, soft tissue pogonion, lateral cantus of the eye and gonion. The first measurement between the tragus-lip corner, the second measurement will be obtained by measuring the horizontal distance between the tragus-soft tissue pogonion. The third measurement will be determined by the measurement of the vertical distance between the outer corner of the eye and the gonion. to determine the change in the swelling measurements performed before surgery and at 2nd-7th days after surgery. | Baseline, 2nd and 7th days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trismus- degree of change (limitation) in maximum mouth opening | The maximum mouth opening will be determined as the distance between the right lower and upper right central. | Baseline, 2nd and 7th days | 
| Post operative Pain: visual analog (VAS) scale | For the evaluation of the pain, the visual analog scale (VAS) will be used to express the absence of pain in the initial part on a straight line (0) and the end part to express the unbearable pain (10). 0 (no pain)--------------------------------------------------------------------------------10 (unbearable pain) Higher values of the scale represent worse outcome. | 6th and 24th hours, 2nd and 7th days | 
| Post-operative symptom severity (PoSSe) scale | The evaluation of the change in postoperative quality of life will be done with a scale of post-operative symptom severity (PoSSe) consisting of 15-item questionnaire in which the effect of operation on eating, speech, sensation, appearance, pain, disease and daily activities is evaluated. This questionnaire was divided into subscales corresponding to seven main adverse effects, andfor each possible answer there was a score ranging from 0 to a variable number. For total possible answer there was a score ranging from 0 to a 97.9. Higher values of the scale represent worse outcome. | Post operative 7th day |