Posterior Mandibular FracturesNCT06970379
T-prf Versus T-prf and Low-level Laser Stimulation on Bone Healing at Posterior Mandibular Fractures
A study testing T-PRF and T-PRF and Laser biomodulation in people with Posterior Mandibular Fractures, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Posterior Mandibular Fractures
- What is being tested?
- T-PRF and T-PRF and Laser biomodulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2024to 21 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffering from posterior mandibular fracture
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Comparison Between T-prf Versus T-prf and Low-level Laser Stimulation on Bone Healing at Posterior Mandibular Fractures (Randomized Clinical Trial)
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
- Being tested
- T-PRF, T-PRF and Laser biomodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-PRFOther
Patients received T-PRF placement at the fracture line.
T-PRF and Laser biomodulationOther
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
| Study group | Role | What they receive |
|---|---|---|
| T-PRF | Experimental | Not described Receives: Other: T-PRF |
| T-PRF and LLLT | Experimental | Not described Receives: Other: T-PRF and Laser biomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
- Clinical signs of re-epithelization (CSR)
- Clinical signs of haemostasias (CSH)
- Clinical signs of inflammation (CSI)
Measured: baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks
Secondary outcomes (2)
change in pain scores
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)
Measured: 24 hrs, 1 week, 4 weeks
change in edema
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)
Measured: baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start30 Mar 2024
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Mandibular FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970379
- Sponsor's protocol ID
- 0855-02/2024
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between T-prf Versus T-prf and Low-level Laser Stimulation on Bone Healing at Posterior Mandibular Fractures (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06970379
- Acronym / sponsor ID
- 0855-02/2024
- Conditions
- Posterior Mandibular Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-PRF | Experimental | Other: T-PRF |
| T-PRF and LLLT | Experimental | Other: T-PRF and Laser biomodulation |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients suffering from posterior mandibular fracture
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-PRFPatients received T-PRF placement at the fracture line. | Other | T-PRF |
| T-PRF and Laser biomodulationSubjects 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 | Other | T-PRF and LLLT |
Primary outcome
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.
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
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 1. Clinical signs of re-epithelization (CSR) 2. Clinical signs of haemostasias (CSH) 3. Clinical signs of inflammation (CSI)
2 secondary outcomes
change in pain scores
Time frame: 24 hrs, 1 week, 4 weeks
change in edema
Time frame: baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-PRF and T-PRF and Laser biomodulation in people with Posterior Mandibular Fractures, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone density (time frame: Baseline and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.