- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07320170
Comparative Effects of CGF and PRP in Impacted Third Molar Surgery
Evaluation of the Effects of Platelet-rich Plasma and Concentrated Growth Factor on Postoperative Pain, Swelling, and Alveolar Osteitis After Mandibular Third Molar Surgery: a Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective, randomized, controlled clinical trial compares the efficacy of autologous platelet concentrates in reducing postoperative sequelae following the surgical extraction of impacted mandibular third molars.
A total of 42 patients were randomly assigned to one of three groups:
Control Group: Standard surgical extraction without additional biomaterials.
CGF Group: Standard extraction followed by the placement of a CGF clot into the extraction socket.
PRP Group: Standard extraction followed by submucosal injection of PRP.
The primary outcome measured is postoperative pain (Visual Analog Scale) on postoperative days 1, 3, and 7. The secondary outcomes include facial swelling (linear measurements) on postoperative days 1, 3, and 7, and the incidence of alveolar osteitis (dry socket).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Rize, Turkey (Türkiye)
- Recep Tayyip Erdogan University, Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged between 18 and 50 years.
- Systemically healthy individuals classified as American Society of Anesthesiologists (ASA) Class I or Class II.
- Presence of impacted mandibular third molars (teeth 38 and 48 according to Fédération Dentaire Internationale (FDI) notation).
- Mesioangular impaction with bone retention according to Winter's classification.
- Class II relationship to the ramus according to the Pell and Gregory classification.
- Level B or Level C depth of impaction according to the Pell and Gregory classification.
Exclusion Criteria:
- Patients younger than 18 years.
- Habitual smoking or alcohol consumption.
- Presence of coagulation (bleeding) disorders.
- Systemic diseases affecting wound healing or use of medications that compromise healing.
- Pregnancy or lactation.
- Presence of active pericoronitis associated with the tooth.
- Presence of pathological lesions (cysts or tumors) associated with the impacted tooth.
- Uncontrolled periodontal disease in the oral cavity.
- Known allergy to any medications used in the study protocol.
- Inability to comply with follow-up visits.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Standard surgical extraction was performed without the application of any additional biomaterials.
|
|
|
Experimental: CGF Group
Standard surgical extraction followed by the placement of a Concentrated Growth Factor (CGF) clot into the extraction socket.
|
Standard surgical extraction followed by the placement of a Concentrated Growth Factor (CGF) clot into the extraction socket immediately after tooth removal.
|
|
Experimental: PRP Group
Standard surgical extraction followed by submucosal injection of Platelet-Rich Plasma (PRP).
|
Standard surgical extraction followed by submucosal injection of Platelet-Rich Plasma (PRP) around the extraction site.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain
Time Frame: Postoperative days 1, 3, and 7.
|
Assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
|
Postoperative days 1, 3, and 7.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facial Swelling
Time Frame: Preoperative and Postoperative days 1, 3, and 7.
|
Measured using linear distances between specific facial landmarks (tragus to mouth commissure, tragus to pogonion, lateral canthus to mandibular angulus) to evaluate edema.
|
Preoperative and Postoperative days 1, 3, and 7.
|
|
Incidence of Alveolar Osteitis
Time Frame: Postoperative days 1, 3, and 7
|
Evaluated based on clinical signs such as loss of blood clot, intense throbbing pain, and halitosis (dry socket).
|
Postoperative days 1, 3, and 7
|
Collaborators and Investigators
Sponsor
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 (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024/52
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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