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
1 other identifier
interventional
75
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2018
CompletedFirst Submitted
Initial submission to the registry
September 26, 2018
CompletedFirst Posted
Study publicly available on registry
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2019
CompletedAugust 28, 2019
August 1, 2019
8 months
September 26, 2018
August 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Trismus- degree of change (limitation) in maximum mouth opening
Baseline, 2nd and 7th days
Post operative Pain: visual analog (VAS) scale
6th and 24th hours, 2nd and 7th days
Post-operative symptom severity (PoSSe) scale
Post operative 7th day
Study Arms (3)
Concentrated Growth Factor (CGF)
ACTIVE COMPARATORParticipants with impacted lower third molar
Advanced Platelet Rich Fibrin (A-PRF)
ACTIVE COMPARATORParticipants with impacted lower third molar
Control
SHAM COMPARATORParticipants with impacted lower third molar
Interventions
CGF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for CGF)
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Damla Torullead
Study Sites (1)
Ordu University
Ordu, 52200, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Damla Torul, PhD
Ordu University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Asistant, Oral and Maxillofacial Surgery
Study Record Dates
First Submitted
September 26, 2018
First Posted
October 1, 2018
Study Start
July 12, 2018
Primary Completion
March 1, 2019
Study Completion
March 20, 2019
Last Updated
August 28, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share
IPD can share with other researchers on demand