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

Not Applicable

Completed

• Conditions: Posterior Mandibular Fractures

• Registration Number: NCT06970379
• Lead Sponsor: Alexandria University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-30
• Primary Completion: 2025-01-21
• Study Completion: 2025-01-21
• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Azarita, Egypt