Impacted Mandibular Third MolarNCT07604584
Effects of Platelet-Rich Fibrin After Mandibular Third Molar Surgery in Smokers and Nonsmokers
A study testing Platelet-Rich Fibrin in people with Impacted Mandibular Third Molar and Postoperative Pain, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Mandibular third molar surgery is commonly associated with postoperative pain, swelling, and trismus. Platelet-rich fibrin (PRF) has been proposed as a biological adjunct to improve postoperative healing; however, its effectiveness in smokers remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Impacted Mandibular Third Molar, Postoperative Pain, Trismus
- What is being tested?
- Platelet-Rich Fibrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2017to 21 Dec 2018
- 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
- Systemically healthy patients aged between 18 and 35 years
- Bilaterally impacted mandibular third molars
- Mandibular third molars classified as Pell and Gregory Class I, Position C
- Mandibular third molars classified as Parant Class II difficulty
- Smoking and nonsmoking patients
- Patients willing to participate and provide written informed consent
Who cannot join
- Presence of acute infection or pericoronitis
- Pregnancy or lactation
- Alcohol or substance abuse
- Use of oral contraceptives
- Menstrual period during surgery
- Antibiotic use within the previous month
Show all 10Show fewer
- Smoking more than 10 cigarettes per day
- Agitation or inability to cooperate
- Incomplete follow-up data
- Systemic disease contraindicating oral surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, 06560
About this study
Official title: Effects of Platelet-Rich Fibrin on Postoperative Pain, Trismus and Swelling After Impacted Mandibular Third Molar Surgery in Smokers and Nonsmokers: A Prospective Clinical Study
Mandibular third molar surgery is commonly associated with postoperative pain, swelling, and trismus. Platelet-rich fibrin (PRF) has been proposed as a biological adjunct to improve postoperative healing; however, its effectiveness in smokers remains unclear. This prospective randomized split-mouth clinical study aimed to evaluate the effects of PRF on postoperative pain, swelling, trismus, and analgesic consumption after impacted mandibular third molar surgery in smokers and nonsmokers. Thirty patients with bilaterally impacted mandibular third molars were included. PRF was placed in one extraction socket, while the contralateral socket served as the control site. Postoperative clinical outcomes were assessed during the first postoperative week and compared between smoking and nonsmoking patients.
Read the detailed description
This prospective randomized split-mouth clinical trial was conducted between 2017 and 2019 at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ankara University. The study aimed to evaluate the effects of platelet-rich fibrin (PRF) on postoperative pain, swelling, trismus, and analgesic consumption after impacted mandibular third molar surgery in smoking and nonsmoking patients.
A total of 30 systemically healthy patients aged 18-35 years with bilaterally impacted mandibular third molars were included. Patients were divided into smoking and nonsmoking groups. In each patient, PRF was randomly applied to one extraction socket, while the contralateral socket served as the control site without PRF application. All surgical procedures were performed by the same oral and maxillofacial surgeon using a standardized surgical protocol. Outcome assessments were performed by a different clinician blinded to the intervention side.
Postoperative pain was evaluated using a visual analog scale (VAS). Facial swelling was assessed using linear facial measurements between anatomical landmarks, and trismus was evaluated by measuring maximum interincisal distance. Clinical evaluations were performed preoperatively and on postoperative days 1, 2, 3, and 7.
The primary outcome of the study was postoperative pain intensity. Secondary outcomes included postoperative swelling, trismus, and analgesic consumption. The study also aimed to compare the clinical effectiveness of PRF between smokers and nonsmokers.
- Being tested
- Platelet-Rich Fibrin
- Keywords
- Platelet-Rich Fibrin, Mandibular Third Molar, Postoperative Pain, Smoking, Swelling, Trismus
- Medical subject headings
- Pain, Postoperative, Trismus, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich FibrinBiological
Autologous platelet-rich fibrin prepared from venous blood by centrifugation and placed into the extraction socket after mandibular third molar extraction.
| Study group | Role | What they receive |
|---|---|---|
| PRF-treated socket | Experimental | Platelet-rich fibrin (PRF) was placed into the extraction socket following impacted mandibular third molar surgery. Receives: Biological: Platelet-Rich Fibrin |
| Control socket | No intervention | The contralateral extraction socket was primarily closed without PRF application after mandibular third molar surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity assessed using a 100-mm visual analog scale (VAS) after impacted mandibular third molar surgery.
Measured: Postoperative days 1, 2, 3, and 7
Secondary outcomes (3)
Postoperative Facial Swelling
Postoperative facial swelling assessed using linear facial measurements between anatomical landmarks.
Measured: Preoperative period and postoperative days 1, 2, 3, and 7
Postoperative Trismus
Trismus assessed by measuring maximum interincisal mouth opening distance.
Measured: Preoperative period and postoperative days 1, 2, 3, and 7
Postoperative Analgesic Consumption
Number of analgesic tablets used during the postoperative follow-up period.
Measured: Postoperative days 1, 2, 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 posted22 May 2026
- Study start15 May 2017
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impacted Mandibular Third MolarStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- This study was designed as a prospective randomized split-mouth clinical trial in which PRF was applied to one extraction socket, while the contralateral extraction socket served as the control site without PRF application. Bilateral mandibular third molar extractions were performed at least two weeks apart in the same patients. Smoking status was evaluated as a subgroup factor.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Alp Eriş, Ankara University
- Investigators
- Mehmet Emre Yurttutan, PhD, DDS, Principal investigator, Ankara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604584
- Sponsor's protocol ID
- 36290600/51
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arslan R, Gonc S, Eris MA, Yurttutan ME. Effects of platelet-rich fibrin on postoperative pain, trismus, and swelling after impacted mandibular third molar surgery in smokers and nonsmokers: an exploratory prospective clinical study. J Craniomaxillofac Surg. 2026 Oct 24;54(12):109934. doi: 10.1016/j.jcms.2026.109934. Online ahead of print.
PubMed 42925789
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Platelet-Rich Fibrin on Postoperative Pain, Trismus and Swelling After Impacted Mandibular Third Molar Surgery in Smokers and Nonsmokers: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07604584
- Acronym / sponsor ID
- 36290600/51
- Keywords
- Platelet-Rich Fibrin, Mandibular Third Molar, Postoperative Pain, Smoking, Swelling, Trismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 22 May 2026 (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.
Mandibular third molar surgery is commonly associated with postoperative pain, swelling, and trismus. Platelet-rich fibrin (PRF) has been proposed as a biological adjunct to improve postoperative healing; however, its effectiveness in smokers remains unclear. This prospective randomized split-mouth clinical study aimed to evaluate the effects of PRF on postoperative pain, swelling, trismus, and analgesic consumption after impacted mandibular third molar surgery in smokers and nonsmokers. Thirty patients with bilaterally impacted mandibular third molars were included. PRF was placed in one extraction socket, while the contralateral socket served as the control site. Postoperative clinical outcomes were assessed during the first postoperative week and compared between smoking and nonsmoking patients.
Detailed description
This prospective randomized split-mouth clinical trial was conducted between 2017 and 2019 at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ankara University. The study aimed to evaluate the effects of platelet-rich fibrin (PRF) on postoperative pain, swelling, trismus, and analgesic consumption after impacted mandibular third molar surgery in smoking and nonsmoking patients.
A total of 30 systemically healthy patients aged 18-35 years with bilaterally impacted mandibular third molars were included. Patients were divided into smoking and nonsmoking groups. In each patient, PRF was randomly applied to one extraction socket, while the contralateral socket served as the control site without PRF application. All surgical procedures were performed by the same oral and maxillofacial surgeon using a standardized surgical protocol. Outcome assessments were performed by a different clinician blinded to the intervention side.
Postoperative pain was evaluated using a visual analog scale (VAS). Facial swelling was assessed using linear facial measurements between anatomical landmarks, and trismus was evaluated by measuring maximum interincisal distance. Clinical evaluations were performed preoperatively and on postoperative days 1, 2, 3, and 7.
The primary outcome of the study was postoperative pain intensity. Secondary outcomes included postoperative swelling, trismus, and analgesic consumption. The study also aimed to compare the clinical effectiveness of PRF between smokers and nonsmokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed as a prospective randomized split-mouth clinical trial in which PRF was applied to one extraction socket, while the contralateral extraction socket served as the control site without PRF application. Bilateral mandibular third molar extractions were performed at least two weeks apart in the same patients. Smoking status was evaluated as a subgroup factor.
| Arm | Type | Receives |
|---|---|---|
| PRF-treated socket | Experimental | Biological: Platelet-Rich FibrinPlatelet-rich fibrin (PRF) was placed into the extraction socket following impacted mandibular third molar surgery. |
| Control socket | No intervention | –The contralateral extraction socket was primarily closed without PRF application after mandibular third molar surgery. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Systemically healthy patients aged between 18 and 35 years
- Bilaterally impacted mandibular third molars
- Mandibular third molars classified as Pell and Gregory Class I, Position C
- Mandibular third molars classified as Parant Class II difficulty
- Smoking and nonsmoking patients
Key exclusion criteria (10 listed)
- Presence of acute infection or pericoronitis
- Pregnancy or lactation
- Alcohol or substance abuse
- Use of oral contraceptives
- Menstrual period during surgery
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 FibrinAutologous platelet-rich fibrin prepared from venous blood by centrifugation and placed into the extraction socket after mandibular third molar extraction. | Biological | PRF-treated socket |
Primary outcome
Postoperative Pain Intensity
Time frame: Postoperative days 1, 2, 3, and 7
Postoperative pain intensity assessed using a 100-mm visual analog scale (VAS) after impacted mandibular third molar surgery.
3 secondary outcomes
Postoperative Facial Swelling
Time frame: Preoperative period and postoperative days 1, 2, 3, and 7
Postoperative Trismus
Time frame: Preoperative period and postoperative days 1, 2, 3, and 7
Postoperative Analgesic Consumption
Time frame: Postoperative days 1, 2, 3, and 7
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 22 May 2026.
- Derived from this study: PubMed 42925789Arslan R, Gonc S, Eris MA, Yurttutan ME. Effects of platelet-rich fibrin on postoperative pain, trismus, and swelling after impacted mandibular third molar surgery in smokers and nonsmokers: an exploratory prospective clinical study. J Craniomaxillofac Surg. 2026 Oct 24;54(12):109934. doi: 10.1016/j.jcms.2026.109934. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Mehmet Emre Yurttutan, PhD, DDS principal investigator
Ankara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
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 in people with Impacted Mandibular Third Molar and Postoperative Pain, run by Ankara 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 6 inclusion and 10 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 22 May 2026. 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 Intensity (time frame: Postoperative days 1, 2, 3, and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07604584, which also lists 1 linked publication.
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 22 May 2026.