- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06900894
Effects of Platelet-Rich Fibrin and Kinesio Taping on Postoperative Recovery in Oral Surgery (PRFKTOralSur)
Effectiveness of Platelet-Rich Fibrin and Elastic Bandaging on Postoperative Pain, Edema, and Recovery Following Impacted Molar Surgery: A Randomized Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
This study investigates the effectiveness of Platelet-Rich Fibrin (PRF) and Kinesio Taping in postoperative management following impacted mandibular third molar surgery. Postoperative complications, such as pain and edema, are commonly observed and may impact patient comfort and recovery. This study aims to evaluate the feasibility of two non-pharmacological approaches-PRF and Kinesio Taping (Elastic Bandaging)-in postoperative care.
A total of 44 patients aged 18-35 years participated in this prospective, randomized clinical trial. Patients were assigned to one of three groups:
PRF Group: Platelet-rich fibrin (PRF) was applied locally into the extraction socket.
Kinesio Taping Group: An elastic bandage was applied postoperatively to the surgical area and removed on the third day.
Control Group: Standard postoperative care was provided with no additional intervention.
Postoperative evaluations were conducted on the 3rd and 7th days. The measured parameters included:
Edema: Measured using anthropometric techniques.
Pain: Assessed with the Numerical Rating Scale (NRS).
Quality of Life: Evaluated using the Oral Health Impact Profile-14 (OHIP-14).
This study aims to assess the feasibility of PRF and Kinesio Taping in postoperative management.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hatay, Turkey, 31001
- Hatay Mustafa Kemal University, Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 18-35 years
- Systemically healthy individuals
- Non-smokers
- No psychological disorders
- Preoperative pain level between 0-3 on the Numerical Rating Scale (NRS)
- No preoperative edema in the surgical area
- Impacted mandibular third molars classified as Class 1 or 2, Level B, and mesioangular according to the Pell-Gregory classification
- Signed an informed consent form
Exclusion Criteria:
- Under 18 or over 35 years old
- Presence of chronic or systemic diseases
- Pregnant or breastfeeding patients
- Surgical duration exceeding 45 minutes
- Smokers
- Patients requiring prophylactic antibiotics due to systemic health conditions
- Patients who did not meet the study criteria or did not sign the informed consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRF Group
Participants in this group received Platelet-Rich Fibrin (PRF) applied to the extraction socket following impacted third molar surgery.
PRF was prepared using a centrifugation protocol and placed into the surgical site.
|
PRF was prepared using a centrifugation protocol and applied to the extraction socket.
|
|
Experimental: Kinesio Taping Group
Participants in this group received Kinesio Taping applied postoperatively.
The elastic therapeutic tape was applied to the masseter and submandibular region following a standardized taping protocol.
|
Kinesio Tape was applied postoperatively to the masseter and submandibular region.
|
|
Other: Control Group
Participants in this group received standard postoperative care, including routine pain management and wound care, without additional interventions.
|
Patients in the control group received standard postoperative care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Assessment (NRS)
Time Frame: Preoperative day 1, postoperative days 3 and 7
|
The pain intensity of the patients will be assessed using the Numerical Rating Scale (NRS) on preoperative day 1 and postoperative days 3 and 7. On this scale: 0 indicates no pain, 10 indicates the worst imaginable pain. Before the procedure, patients were informed about the scale and instructed to rate their pain intensity accordingly. |
Preoperative day 1, postoperative days 3 and 7
|
|
Postoperative Facial Swelling Assessment
Time Frame: Preoperative day 1, postoperative days 3 and 7
|
Swelling will be evaluated using anthropometric measurement techniques on preoperative (surgery day), postoperative days 1, 3, and 7. Measurement methods: Lateral canthus-gonion distance (distance from the outer corner of the eye to the mandibular angle) Commissure-tragus distance (distance from the oral commissure to the midpoint of the tragus) All measurements were performed using a flexible ruler, and the results were recorded in millimeters. |
Preoperative day 1, postoperative days 3 and 7
|
|
Oral Health Impact Profile-14 (OHIP-14) Score
Time Frame: Postoperative days 3 and 7
|
The quality of life of the patients will be assessed using the OHIP-14 questionnaire on postoperative days 3 and 7. OHIP-14 consists of 14 standardized items, each rated on a scale from 0 to 4. Total scores range from 0 to 56, with higher scores indicating worse quality of life. This scale was used to evaluate the impact of postoperative complications on patients' quality of life. |
Postoperative days 3 and 7
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: züleyha başar karakuzu, DDS, Mustafa Kemal 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
- PRF_KT2025
- Ethics Committee No. (Registry Identifier: Hatay Clinical Research Ethics Committee - 2023/03)
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
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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