Impacted Mandibular Third Molar ExtractionNCT07748585
Effect of Titanium-Prepared Platelet-Rich Fibrin and Low-Level Laser Therapy on Postoperative Morbidity After Mandibular Third Molar Surgery
A study testing Titanium-Prepared Platelet-Rich Fibrin (T-PRF) and Low-Level Laser Therapy (LLLT) in people with Impacted Mandibular Third Molar Extraction, run by Cyprus Health and Social Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This randomized double-blind clinical trial aims to evaluate the effects of titanium-prepared platelet-rich fibrin (T-PRF), low-level laser therapy (LLLT), and their combination on postoperative outcomes following surgical extraction of impacted mandibular third molars. Read more about this study
- Who is it for?
- Ages 18 to 31 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Mandibular Third Molar Extraction
- What is being tested?
- Titanium-Prepared Platelet-Rich Fibrin (T-PRF) and Low-Level Laser Therapy (LLLT)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2025to 29 Jun 2026
- 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 31 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults requiring surgical extraction of a unilateral vertically impacted mandibular third molar.
- Healthy individuals (ASA I or II).
- Ability to provide written informed consent.
- Willingness to attend all follow-up visits.
Who cannot join
- Systemic disease affecting wound healing.
- Pregnancy or lactation.
- Active infection or acute pericoronitis.
- Long-term opioid use.
- Smoking and alcohol use.
- Known allergy to study medications.
- Previous radiotherapy to the head and neck region
- Inability to attend follow-up visits.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cyprus Health and Social Sciences University, Faculty of Dentistry
Güzelyurt, Güzelyurt, 99700
About this study
Official title: Effects of Titanium-Prepared Platelet-Rich Fibrin and Low-Level Laser Therapy on Postoperative Pain, Swelling, Trismus, and Analgesic Consumption Following Mandibular Third Molar Surgery: A Randomized Double-Blind Clinical Trial
This randomized double-blind clinical trial aims to evaluate the effects of titanium-prepared platelet-rich fibrin (T-PRF), low-level laser therapy (LLLT), and their combination on postoperative outcomes following surgical extraction of impacted mandibular third molars. Sixty patients will be randomly allocated to one of four parallel groups: T-PRF, LLLT, T-PRF plus LLLT, or control. The primary outcomes include postoperative pain assessed using a visual analogue scale (VAS), analgesic consumption, postoperative swelling and trismus. The findings may help identify effective approaches for improving postoperative recovery after mandibular third molar surgery.
- Being tested
- Titanium-Prepared Platelet-Rich Fibrin (T-PRF), Low-Level Laser Therapy (LLLT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium-Prepared Platelet-Rich Fibrin (T-PRF)Procedure or surgery
Titanium-prepared platelet-rich fibrin (T-PRF) was prepared from autologous blood and placed into the extraction socket immediately after mandibular third molar surgery.
Low-Level Laser Therapy (LLLT)Device
Low-level laser therapy was applied using a 650 nm diode laser (25 mW) immediately after surgery and once daily for the following two postoperative days.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants underwent standard surgical extraction of an impacted mandibular third molar without T-PRF placement or active low-level laser therapy. |
| T-PRF | Experimental | Participants received titanium-prepared platelet-rich fibrin (T-PRF) placed into the extraction socket immediately after mandibular third molar surgery. Receives: Procedure: Titanium-Prepared Platelet-Rich Fibrin (T-PRF) |
| LLLT | Experimental | Participants received low-level laser therapy immediately after surgery and once daily for the following two postoperative days. Receives: Device: Low-Level Laser Therapy (LLLT) |
| T-PRF + LLLT | Experimental | Participants received titanium-prepared platelet-rich fibrin (T-PRF) placed into the extraction socket together with low-level laser therapy immediately after surgery and once daily for the following two postoperative days. Receives: Procedure: Titanium-Prepared Platelet-Rich Fibrin (T-PRF); Device: Low-Level Laser Therapy (LLLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative pain assessed using a 100-mm Visual Analog Scale (VAS).
Measured: Postoperative Days 1, 2, 3, and 7
Analgesic Consumption
Number of analgesic tablets consumed after surgery.
Measured: Postoperative Days 1, 2, 3, and 7
Facial Swelling
Postoperative facial swelling will be evaluated using standardized linear facial measurements. Three distances will be measured with a flexible measuring tape: tragus to the corner of the mouth (Tragus-Commissure), tragus to the soft-tissue pogonion (Tragus-Pogonion), and lateral canthus of the eye to the mandibular angle (Lateral Canthus-Gonion). The sum of the three measurements (in centimeters) will be recorded for each participant. Higher values indicate greater postoperative facial swelling.
Measured: Preoperative baseline and Postoperative Days 1, 2, 3, and 7
Maximum Interincisal Mouth Opening (Trismus)
Postoperative trismus will be evaluated by measuring the maximum interincisal mouth opening using a calibrated caliper. The distance (in millimeters) between the incisal edges of the maxillary and mandibular central incisors during maximum mouth opening will be recorded for each participant. Lower values indicate greater postoperative trismus.
Measured: Preoperative baseline and 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 posted5 Aug 2026
- Study start27 Nov 2025
- Primary completion22 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third Molar ExtractionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus Health and Social Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salih Alpcan, Cyprus Health and Social Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748585
- Sponsor's protocol ID
- KSTU//2025/136
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Titanium-Prepared Platelet-Rich Fibrin and Low-Level Laser Therapy on Postoperative Pain, Swelling, Trismus, and Analgesic Consumption Following Mandibular Third Molar Surgery: A Randomized Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07748585
- Acronym / sponsor ID
- KSTU//2025/136
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cyprus Health and Social Sciences UniversityUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 5 Aug 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.
This randomized double-blind clinical trial aims to evaluate the effects of titanium-prepared platelet-rich fibrin (T-PRF), low-level laser therapy (LLLT), and their combination on postoperative outcomes following surgical extraction of impacted mandibular third molars. Sixty patients will be randomly allocated to one of four parallel groups: T-PRF, LLLT, T-PRF plus LLLT, or control. The primary outcomes include postoperative pain assessed using a visual analogue scale (VAS), analgesic consumption, postoperative swelling and trismus. The findings may help identify effective approaches for improving postoperative recovery after mandibular third molar surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants underwent standard surgical extraction of an impacted mandibular third molar without T-PRF placement or active low-level laser therapy. |
| T-PRF | Experimental | Procedure: Titanium-Prepared Platelet-Rich Fibrin (T-PRF)Participants received titanium-prepared platelet-rich fibrin (T-PRF) placed into the extraction socket immediately after mandibular third molar surgery. |
| LLLT | Experimental | Device: Low-Level Laser Therapy (LLLT)Participants received low-level laser therapy immediately after surgery and once daily for the following two postoperative days. |
| T-PRF + LLLT | Experimental | Procedure: Titanium-Prepared Platelet-Rich Fibrin (T-PRF), Device: Low-Level Laser Therapy (LLLT)Participants received titanium-prepared platelet-rich fibrin (T-PRF) placed into the extraction socket together with low-level laser therapy immediately after surgery and once daily for the following two postoperative days. |
Who may qualify
- Ages
- 18 to 31 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults requiring surgical extraction of a unilateral vertically impacted mandibular third molar.
- Healthy individuals (ASA I or II).
- Ability to provide written informed consent.
- Willingness to attend all follow-up visits.
Key exclusion criteria (8 listed)
- Systemic disease affecting wound healing.
- Pregnancy or lactation.
- Active infection or acute pericoronitis.
- Long-term opioid use.
- Smoking and alcohol use.
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 |
|---|---|---|
| Titanium-Prepared Platelet-Rich Fibrin (T-PRF)Titanium-prepared platelet-rich fibrin (T-PRF) was prepared from autologous blood and placed into the extraction socket immediately after mandibular third molar surgery. | Procedure or surgery | T-PRF, T-PRF + LLLT |
| Low-Level Laser Therapy (LLLT)Low-level laser therapy was applied using a 650 nm diode laser (25 mW) immediately after surgery and once daily for the following two postoperative days. | Device | LLLT, T-PRF + LLLT |
Primary outcome
Postoperative Pain
Time frame: Postoperative Days 1, 2, 3, and 7
Postoperative pain assessed using a 100-mm Visual Analog Scale (VAS).
Analgesic Consumption
Time frame: Postoperative Days 1, 2, 3, and 7
Number of analgesic tablets consumed after surgery.
Facial Swelling
Time frame: Preoperative baseline and Postoperative Days 1, 2, 3, and 7
Postoperative facial swelling will be evaluated using standardized linear facial measurements. Three distances will be measured with a flexible measuring tape: tragus to the corner of the mouth (Tragus-Commissure), tragus to the soft-tissue pogonion (Tragus-Pogonion), and lateral canthus of the eye to the mandibular angle (Lateral Canthus-Gonion). The sum of the three measurements (in centimeters) will be recorded for each participant. Higher values indicate greater postoperative facial swelling.
Maximum Interincisal Mouth Opening (Trismus)
Time frame: Preoperative baseline and Postoperative Days 1, 2, 3, and 7
Postoperative trismus will be evaluated by measuring the maximum interincisal mouth opening using a calibrated caliper. The distance (in millimeters) between the incisal edges of the maxillary and mandibular central incisors during maximum mouth opening will be recorded for each participant. Lower values indicate greater postoperative trismus.
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 24 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titanium-Prepared Platelet-Rich Fibrin (T-PRF) and Low-Level Laser Therapy (LLLT) in people with Impacted Mandibular Third Molar Extraction, run by Cyprus Health and Social Sciences 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 4 inclusion and 8 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 24 Sep 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 (time frame: Postoperative Days 1, 2, 3, and 7). The study lists 4 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 24 Sep 2026.