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

NCT06970379 — Not applicable, Completed, 14 participants, Alexandria University

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

Registry	NCT06970379
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	14 (Actual)
Sponsor	Alexandria University (Other)
Conditions	Posterior Mandibular Fractures
Interventions	T-PRF, T-PRF and Laser biomodulation (Other)
Dates	start 2024-03-30, primary completion 2025-01-21, completion 2025-01-21, first posted 2025-05-14, last updated 2025-05-14
Locations	1 site in Egypt

-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

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+Arms and interventions

Arm	Type	Interventions	Description
T-PRF	Experimental	Other: T-PRF
T-PRF and LLLT	Experimental	Other: T-PRF and Laser biomodulation

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

+Outcome measures

Primary outcomes

Change in bone density [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.
Change in mouth opening [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
Change in wound healing [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 1. Clinical signs of re-epithelization (CSR) 2. Clinical signs of haemostasias (CSH) 3. Clinical signs of inflammation (CSI)

Secondary outcomes

change in pain scores [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)
change in edema [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)

+Eligibility

Sex: All, ages: 20 Years to 40 Years

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.

+Locations (1)

Facility	City	Country	Status
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria, Azarita	Egypt

My Notes

Public

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