Effect of Titanium-Prepared Platelet-Rich Fibrin and Low-Level Laser Therapy on Postoperative Morbidity After Mandibular Third Molar Surgery

NCT07748585 | Completed

• 1 other identifier: KSTU//2025/136
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Impacted Mandibular Third Molar Extraction

Outcome Measures

Primary Outcomes (4)

• Postoperative Pain

  Postoperative pain assessed using a 100-mm Visual Analog Scale (VAS).

  Postoperative Days 1, 2, 3, and 7

• Analgesic Consumption

  Number of analgesic tablets consumed after surgery.

  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.

  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 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.

  Preoperative baseline and Postoperative Days 1, 2, 3, and 7

Study Arms (4)

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.

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.

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.

Procedure: Titanium-Prepared Platelet-Rich Fibrin (T-PRF); Device: Low-Level Laser Therapy (LLLT)

Interventions

Titanium-Prepared Platelet-Rich Fibrin (T-PRF) PROCEDURE

Titanium-prepared platelet-rich fibrin (T-PRF) was prepared from autologous blood and placed into the extraction socket immediately after mandibular third molar surgery.

T-PRF; T-PRF + LLLT

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.

LLLT; T-PRF + LLLT

Eligibility Criteria

• Age: 18 Years - 31 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NEW Cyprus Health and Social Sciences University: lead

Study Sites (1)

Cyprus Health and Social Sciences University, Faculty of Dentistry

Güzelyurt, Güzelyurt, 99700, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: December 27, 2025
• Primary Completion: June 22, 2026
• Study Completion: June 29, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-08

Locations

TU (1)