Impacted Third Molar ToothPRFKTOralSurNCT06900894
Effects of Platelet-Rich Fibrin and Kinesio Taping on Postoperative Recovery in Oral Surgery
A study testing Platelet-Rich Fibrin (PRF), Kinesio Taping and Standard Postoperative Care in people with Impacted Third Molar Tooth and Postoperative Pain, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effectiveness of Platelet-Rich Fibrin (PRF) and Kinesio Taping in reducing postoperative pain, edema, and improving recovery following impacted third molar surgery. A prospective, randomized clinical trial was conducted with 44 patients aged 18-35 years. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Impacted Third Molar Tooth, Postoperative Pain, Postoperative Edema
- What is being tested?
- Platelet-Rich Fibrin (PRF), Kinesio Taping and Standard Postoperative Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 21 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University, Faculty of Dentistry
Hatay, 31001
About this study
Official title: Effectiveness of Platelet-Rich Fibrin and Elastic Bandaging on Postoperative Pain, Edema, and Recovery Following Impacted Molar Surgery: A Randomized Clinical Trial
This study investigates the effectiveness of Platelet-Rich Fibrin (PRF) and Kinesio Taping in reducing postoperative pain, edema, and improving recovery following impacted third molar surgery. A prospective, randomized clinical trial was conducted with 44 patients aged 18-35 years. Patients were assigned to three groups: (1) PRF applied locally to the extraction socket, (2) Kinesio Taping applied postoperatively and removed on the third day, and (3) a control group receiving standard postoperative care. Postoperative outcomes were assessed on days 3 and 7, including pain levels, edema, and quality of life. This study aims to evaluate PRF and Kinesio Taping as non-pharmacological adjuncts in oral and maxillofacial surgery.
Read the 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.
- Being tested
- Platelet-Rich Fibrin (PRF), Kinesio Taping, Standard Postoperative Care
- Keywords
- Impacted third molar, elastic bandage, platelet-rich fibrin, postoperative pain, quality of life, Postoperative Edema
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Fibrin (PRF)Biological
PRF was prepared using a centrifugation protocol and applied to the extraction socket.
Kinesio TapingDevice
Kinesio Tape was applied postoperatively to the masseter and submandibular region.
Standard Postoperative CareOther
Patients in the control group received standard postoperative care.
| Study group | Role | What they receive |
|---|---|---|
| PRF Group | Experimental | 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. Receives: Biological: Platelet-Rich Fibrin (PRF) |
| Kinesio Taping Group | Experimental | 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. Receives: Device: Kinesio Taping |
| Control Group | Other | Participants in this group received standard postoperative care, including routine pain management and wound care, without additional interventions. Receives: Other: Standard Postoperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Assessment (NRS)
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.
Measured: Preoperative day 1, postoperative days 3 and 7
Postoperative Facial Swelling Assessment
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.
Measured: Preoperative day 1, postoperative days 3 and 7
Oral Health Impact Profile-14 (OHIP-14) Score
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.
Measured: Postoperative days 3 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Oct 2023
- Primary completion10 Jan 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study follows a parallel assignment model in which participants are randomly allocated into three groups: Platelet-Rich Fibrin (PRF), Kinesio Taping, and Control. Each group receives a distinct intervention to evaluate the effectiveness of these non-pharmacological approaches in managing postoperative pain, edema, and recovery following impacted third molar surgery.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, züleyha başar karakuzu, Mustafa Kemal University
- Investigators
- züleyha başar karakuzu, DDS, Principal investigator, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900894
- Sponsor's protocol ID
- PRF_KT2025
- Other IDs
- Ethics Committee No.
- Acronym
- PRFKTOralSur
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) collected during the study will not be shared due to confidentiality and ethical considerations. Data will only be used for statistical analysis and publication purposes in an aggregated and anonymized form.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Platelet-Rich Fibrin and Elastic Bandaging on Postoperative Pain, Edema, and Recovery Following Impacted Molar Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06900894
- Acronym / sponsor ID
- PRFKTOralSur / PRF_KT2025
- Keywords
- Impacted third molar, elastic bandage, platelet-rich fibrin, postoperative pain, quality of life, Postoperative Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effectiveness of Platelet-Rich Fibrin (PRF) and Kinesio Taping in reducing postoperative pain, edema, and improving recovery following impacted third molar surgery. A prospective, randomized clinical trial was conducted with 44 patients aged 18-35 years. Patients were assigned to three groups: (1) PRF applied locally to the extraction socket, (2) Kinesio Taping applied postoperatively and removed on the third day, and (3) a control group receiving standard postoperative care. Postoperative outcomes were assessed on days 3 and 7, including pain levels, edema, and quality of life. This study aims to evaluate PRF and Kinesio Taping as non-pharmacological adjuncts in oral and maxillofacial surgery.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study follows a parallel assignment model in which participants are randomly allocated into three groups: Platelet-Rich Fibrin (PRF), Kinesio Taping, and Control. Each group receives a distinct intervention to evaluate the effectiveness of these non-pharmacological approaches in managing postoperative pain, edema, and recovery following impacted third molar surgery.
| Arm | Type | Receives |
|---|---|---|
| PRF Group | Experimental | Biological: Platelet-Rich Fibrin (PRF)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. |
| Kinesio Taping Group | Experimental | Device: Kinesio TapingParticipants 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. |
| Control Group | Other | Other: Standard Postoperative CareParticipants in this group received standard postoperative care, including routine pain management and wound care, without additional interventions. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ages 18-35 years
- Systemically healthy individuals
- Non-smokers
- No psychological disorders
- Preoperative pain level between 0-3 on the Numerical Rating Scale (NRS)
Key exclusion criteria (7 listed)
- Under 18 or over 35 years old
- Presence of chronic or systemic diseases
- Pregnant or breastfeeding patients
- Surgical duration exceeding 45 minutes
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-Rich Fibrin (PRF)PRF was prepared using a centrifugation protocol and applied to the extraction socket. | Biological | PRF Group |
| Kinesio TapingKinesio Tape was applied postoperatively to the masseter and submandibular region. | Device | Kinesio Taping Group |
| Standard Postoperative CarePatients in the control group received standard postoperative care. | Other | Control Group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) collected during the study will not be shared due to confidentiality and ethical considerations. Data will only be used for statistical analysis and publication purposes in an aggregated and anonymized form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
züleyha başar karakuzu, DDS principal investigator
Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Fibrin (PRF), Kinesio Taping and Standard Postoperative Care in people with Impacted Third Molar Tooth and Postoperative Pain, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Assessment (NRS) (time frame: Preoperative day 1, postoperative days 3 and 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.