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

NCT06970379 | Completed

• 1 other identifier: 0855-02/2024
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Posterior Mandibular Fractures

Outcome Measures

Primary Outcomes (3)

• Change in bone density

  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.

  Baseline and 3 months

• Change in mouth opening

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

  baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks

• Change in wound healing

  Early Wound Healing Score (EHS) the following will be assessed and each will be scored from 0 to 2 1. Clinical signs of re-epithelization (CSR) 2. Clinical signs of haemostasias (CSH) 3. Clinical signs of inflammation (CSI)

  baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks

Secondary Outcomes (2)

• change in pain scores

  24 hrs, 1 week, 4 weeks

• change in edema

  baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks

Study Arms (2)

T-PRF

EXPERIMENTAL

Other: T-PRF

T-PRF and LLLT

EXPERIMENTAL

Other: T-PRF and Laser biomodulation

Interventions

T-PRF OTHER

Patients received T-PRF placement at the fracture line.

T-PRF

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

T-PRF and LLLT

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients suffering from posterior mandibular fracture

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

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

Alexandria, Azarita, 00203, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 14, 2025
• Study Start: March 30, 2024
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)