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Completed

NCT Number: NCT06970379

T-prf Versus T-prf and Low-level Laser Stimulation on Bone Healing at Posterior Mandibular Fractures

Different types of grafting substances have been used in the recent decade to accelerate bone healing at large bony facial defects. PRF was one of the gold standard materials to be used until it was replaced by its successor T-PRF due to the PRF hazards of preparation. However, T-PRF- still can't stand alone in full bone enhancement procedure. Therefore, the combination with another bone bio-modulation technique, like Low-level Laser Therapy, is a must to approach the full advantage of bone healing. Aim: To compare between the effect of using T-PRF versus T-PRF with Low Level Laser stimulation on bone healing at posterior mandibular fractures

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Key information

Conditions

Posterior Mandibular Fractures

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suffering from posterior mandibular fracture

Exclusion criteria

  • Patients with an untreated old Mandibular fracture.
  • Patient with hematological diseases (thrombocytopenia, hemorrhagic disease, and diabetes).
  • Comminuted fracture with bone loss.
  • There is an infection at the fracture line.

Treatment and study plan

T-PRF

Other

Patients received T-PRF placement at the fracture line.

T-PRF and Laser biomodulation

Other

Subjects underwent the process of bio-stimulation of the fracture line using low-level laser therapy. Wavelength [λ]: 660 nm, Power: 100 mW, Spot size [Ø]: 0.06 cm2, and for 60 seconds

Primary outcomes

  1. Change in bone density

    Time frame: Baseline and 3 months

    immediate postoperative CT-scan will be performed and compared with another CT-scan done 12 weeks (3 months) later. The on-demand software (OnDemand 3D APP-DBM, Cybermed, Seoul, South Korea) will be used to calculate bone mineral density in Hounsfield Units (HU). Six measurements will be taken along the fracture line, and the mean will be measured for each patient.

  2. Change in mouth opening

    Time frame: baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks

    With the help of a millimeter ruler, the maximal inter-incisal distance is going to be assessed

  3. Change in wound healing

    Time frame: baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks

    Early Wound Healing Score (EHS) the following will be assessed and each will be scored from 0 to 2

    • Clinical signs of re-epithelization (CSR)
    • Clinical signs of haemostasias (CSH)
    • Clinical signs of inflammation (CSI)

Secondary outcomes

  1. change in pain scores

    Time frame: 24 hrs, 1 week, 4 weeks

    10-point Visual Analogue Scale (VAS) will be used. A scale of zero to ten (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

  2. change in edema

    Time frame: baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks

    The grading of edema is determined by pit depth (measured visually) and recovery time Ranged from grade 0 (No clinical edema) to grade 4 (Very deep pit (8 mm), more than 30 seconds to rebound)

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Comparison Between T-prf Versus T-prf and Low-level Laser Stimulation on Bone Healing at Posterior Mandibular Fractures (Randomized Clinical Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.