Back to resultsInvestigation of the Effects of CGF and A-PRF on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery
Primary Purpose
Trismus, Edema, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Concentrated Growth Factor (CGF)
Advanced Platelet Rich Fibrin (A-PRF)
Control
Sponsored by
About this trial
This is an interventional treatment trial for Trismus
Eligibility Criteria
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
Sites / Locations
- Ordu University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Concentrated Growth Factor (CGF)
Advanced Platelet Rich Fibrin (A-PRF)
Control
Arm Description
Participants with impacted lower third molar
Participants with impacted lower third molar
Participants with impacted lower third molar
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03690167
Brief Title
Investigation of the Effects of CGF and A-PRF on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Damla Torul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trismus, Edema, Pain, Post-Op Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concentrated Growth Factor (CGF)
Arm Type
Active Comparator
Arm Description
Participants with impacted lower third molar
Arm Title
Advanced Platelet Rich Fibrin (A-PRF)
Arm Type
Active Comparator
Arm Description
Participants with impacted lower third molar
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Participants with impacted lower third molar
Intervention Type
Other
Intervention Name(s)
Concentrated Growth Factor (CGF)
Intervention Description
CGF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for CGF)
Intervention Type
Other
Intervention Name(s)
Advanced Platelet Rich Fibrin (A-PRF)
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Nothing applied after extraction
Primary Outcome Measure Information:
Title
Edema-amount change of swelling
Description
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.
Time Frame
Baseline, 2nd and 7th days
Secondary Outcome Measure Information:
Title
Trismus- degree of change (limitation) in maximum mouth opening
Description
The maximum mouth opening will be determined as the distance between the right lower and upper right central.
Time Frame
Baseline, 2nd and 7th days
Title
Post operative Pain: visual analog (VAS) scale
Description
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.
Time Frame
6th and 24th hours, 2nd and 7th days
Title
Post-operative symptom severity (PoSSe) scale
Description
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.
Time Frame
Post operative 7th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damla Torul, PhD
Organizational Affiliation
T.C. ORDU ÜNİVERSİTESİ
Official's Role
Study Director
Facility Information:
Facility Name
Ordu University
City
Ordu
ZIP/Postal Code
52200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD can share with other researchers on demand
Learn more about this trial
Investigation of the Effects of CGF and A-PRF on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery
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