- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06918327
Effect of CGF on Postoperative Pain After Third Molar Surgery
The Power of Concentrated Growth Factor: A New Era in Pain Management in Third Molar Surgery
The purpose of this study is to evaluate the effects of concentrated growth factor (CGF) on pain after bilateral impacted third molar surgery and to determine its contribution to the healing process.
The main question it aims to answer is:
Is CGF effective on reducing the pain in impacted third molar surgery? Researchers compare the pain on the CGF-applied and CGF free sides after impacted third molar surgery. Postoperative pain is assessed using the Visual Analogue Scale. TThe postoperative outcomes including pain are clinically assessed at different-time intervals (1-7 days).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bornova
-
Izmir, Bornova, Turkey, 35040
- Ege University Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with bilateral, symmetrical, bone-retained (vertical, mesioangular, horizontal) impacted wisdom teeth in the mandible, regardless of gender
- Patients without any systemic disease
- Patients who have been informed about the duration, purpose and requirements of the study and who have signed the informed consent form voluntarily.
Exclusion Criteria:
- Having a disease affecting general health that requires the application of prophylactic antimicrobial agents
- Having a systemic viral, fungal or bacterial infection
- Patients with acute or chronic maxillary sinusitis
- Suspected or diagnosed pregnancy and nursing mothers
- Patients with heart and vascular diseases
- Patients with liver disease, haematological disease and neoplastic disease
- Patients who have recently received anti-inflammatory therapy
- Patients with chronic medication use (antihistamines, NSAIDs, steroids and antidepressants)
- Patients predisposed to psychotic or psychopathic tendencies
- Patients with rheumatic diseases, blood diseases, diabetes mellitus
- Patients at cardiological risk of infective endocarditis
- Patients under antibiotic pressure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CGF
Participants received CGF after the operation on one side
|
Bilaterally impacted third molar of the patients are removed surgically and concentrated growth factor is placed in one of the extraction sockets.
The other extraction socket is left empty for control purposes.
|
|
No Intervention: non-CGF
The other extraction socket is left empty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain on CGF-applied and CGF free sides in bilateral impacted third molar surgery
Time Frame: The postoperative outcomes including pain are clinically assessed at different-time intervals (1st, 2nd, 3rd, 4th, 5th, 6th and 7th days).
|
The primary outcome measure is postoperative pain on CGF-applied and CGF free sides in bilateral impacted third molar surgery.
Postoperative pain is assessed using the Visual Analogue Scale (VAS).
Patients are asked to mark the pain they felt on the scale (10 cm long line) on the (1-7) days after the operation.
The end of the line indicates unbearable pain, the beginning indicates no pain.
|
The postoperative outcomes including pain are clinically assessed at different-time intervals (1st, 2nd, 3rd, 4th, 5th, 6th and 7th days).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mert Zeytinoğlu, Ege University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGE-DHF-MZ-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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