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

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

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

Study Overview

• Status: Completed
• Conditions: Pain; Edema; Trismus; Post-Op Complication
• Intervention / Treatment: Other: Concentrated Growth Factor (CGF); Other: Advanced Platelet Rich Fibrin (A-PRF); Other: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ordu, Turkey, 52200
    • Ordu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Damla Torul
• Investigators: Study Director: Damla Torul, PhD, T.C. ORDU ÜNİVERSİTESİ

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 20, 2019

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Spasm; Edema; Postoperative Complications; Trismus; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 2018/163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD can share with other researchers on demand

Drug and device information, study documents

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