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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative Pain
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Participants and the outcome assessor were blinded to treatment allocation. Randomization was performed using a lottery-based allocation method by an independent staff member. The operating surgeon, who performed the assigned intervention, was not involved in postoperative outcome assessment.
Eligibility Criteria
- Ages
- 18 Years to 31 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Control
Participants underwent standard surgical extraction of an impacted mandibular third molar without T-PRF placement or active low-level laser therapy.
T-PRF
Participants received titanium-prepared platelet-rich fibrin (T-PRF) placed into the extraction socket immediately after mandibular third molar surgery.
Intervention: Titanium-Prepared Platelet-Rich Fibrin (T-PRF) (Procedure)
LLLT
Participants received low-level laser therapy immediately after surgery and once daily for the following two postoperative days.
Intervention: Low-Level Laser Therapy (LLLT) (Device)
T-PRF + 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.
Intervention: Titanium-Prepared Platelet-Rich Fibrin (T-PRF) (Procedure)
T-PRF + 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.
Intervention: Low-Level Laser Therapy (LLLT) (Device)
Outcomes
Primary Outcomes
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 ruler. 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Salih Alpcan
Principal Investigator
NEW Cyprus Health and Social Sciences University