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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690167
• Other study ID #: 2018/163
• Status: Completed
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: March 20, 2019

Study information

• Verified date: August 2019
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 20, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Pain
• Post-Op Complication
• Postoperative Complications
• Trismus

Intervention

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)
• 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)
• Control
Nothing applied after extraction

Locations

Country	Name	City	State
Turkey	Ordu University	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Damla Torul

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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