Posterior Mandibular Fractures
Conditions
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
Interventions
OTHERT-PRF
Patients received T-PRF placement at the fracture line.
OTHERT-PRF and Laser biomodulation
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
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Egypt
Outcome results
None listed