An interventional study of Autologous Platelet-Rich Plasma (PRP) and Open Reduction and Internal Fixation With Titanium Miniplates in Mandibular Fractures and Maxillary Fractures, sponsored by CMH Lahore Medical College and Institute of Dentistry. Recruiting at 2 sites in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by CMH Lahore Medical College and Institute of Dentistry · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if platelet-rich plasma (PRP) made from the patient's own blood helps broken jaw bones heal faster and stronger in adults with fractures of the upper jaw (maxilla) or lower jaw (mandible).
The main questions it aims to answer are:
Researchers will compare patients who receive standard fracture fixation with titanium plates plus PRP to patients who receive the same fixation without PRP, to see if PRP improves bone healing.
Participants will:
Background and rationale:
Fractures of the maxilla and mandible are common in facial trauma and require rapid, reliable bone healing to restore chewing function and facial appearance. Conventional management with rigid internal fixation is effective, but delayed union and incomplete bone regeneration still occur. Autologous platelet-rich plasma (PRP) contains high concentrations of growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-beta), and vascular endothelial growth factor (VEGF), which promote osteogenesis and angiogenesis. Because it is prepared from the patient's own blood, PRP is biocompatible, low-cost, and carries minimal risk of immune reaction. Randomized trials have reported higher radiographic bone density and faster healing with PRP in mandibular fractures; however, a recent systematic review and meta-analysis found that available trials are limited almost entirely to the mandible and that pooled estimates are heterogeneous. Evidence on PRP in maxillary trauma is scarce, and no randomized trial has assessed PRP in both maxillary and mandibular fractures within the same cohort using a standardized CBCT-based protocol.
Study design and setting:
Single-centre, parallel-group, two-arm randomized controlled trial at the Maxillofacial Center, CMH Lahore Medical College and Institute of Dentistry, Lahore, Pakistan.
Randomization and masking:
Eligible patients will be allocated in a 1:1 ratio using a computer-generated randomization list, stratified by fracture site (maxilla or mandible). Allocation will be concealed in sequentially numbered, sealed, opaque envelopes opened in the operating theatre. The investigator measuring bone density on CBCT will be blinded to group allocation.
PRP preparation:
Twelve ml of venous blood will be drawn into sodium citrate tubes and processed at room temperature by double centrifugation: 1200 rpm for 20 minutes to separate plasma, then 2000 rpm for 15 minutes to concentrate platelets. The platelet-rich fraction will be retained and platelet-poor plasma discarded. Platelet count and smear will be performed to confirm concentration and morphology. Immediately before use, PRP will be activated with calcium chloride and bovine thrombin to form a platelet gel.
Surgical procedure:
All operations will be performed under general anaesthesia by the same surgical team. The fracture will be exposed through a vestibular incision, reduced manually, and fixed with two titanium miniplates and screws. In the PRP group, activated PRP gel will be applied along the fracture line before closure; the control group will receive identical fixation without PRP. Wounds will be closed with Vicryl sutures. All patients will receive antibiotics and anti-inflammatory medication for one week and intermittent cold packs for 24 hours.
Outcome assessment:
CBCT scans will be obtained at 1 week, 3 months, and 6 months postoperatively. Bone density will be measured in Hounsfield units within a 3 x 2.5 mm rectangular region of interest placed across the fracture line above the upper plate, using Planmeca software.
Sample size:
A sample of 40 patients (20 per group) was calculated with the OpenEpi calculator from the difference in mean bone density between PRP and control groups reported in a previous randomized trial using the same PRP technique and CBCT schedule (Daif, 2013), with a two-sided significance level of 5% and 80% power.
Statistical analysis:
Data will be analysed in SPSS and presented as mean and standard deviation. Bone density between groups at each time point will be compared with the independent-samples t-test, and change over time within each group with repeated-measures ANOVA. Maxillary and mandibular fractures will be analysed separately as a secondary, exploratory comparison. A p-value below 0.05 will be considered statistically significant.
Ethics:
The study will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants, and confidentiality of patient data will be maintained.
91 studies on the registry are indexed under Mandibular Fractures; 24 are open to participants now.
This study's planned enrollment of 40 is above the median of 21 across 72 interventional studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →CMH Lahore Medical College and Institute of Dentistry is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo open reduction and internal fixation of the maxillary or mandibular fracture under general anaesthesia with two titanium miniplates and screws. Autologous platelet-rich plasma is prepared from 12 ml of the patient's venous blood by double centrifugation, activated with calcium chloride and bovine thrombin, and applied as a gel along the fracture line before wound closure. Postoperatively, patients receive antibiotics and anti-inflammatory medication for one week.
Biological: Autologous Platelet-Rich Plasma (PRP)
Patients undergo open reduction and internal fixation of the maxillary or mandibular fracture under general anaesthesia with two titanium miniplates and screws, identical to the experimental arm, without application of platelet-rich plasma. Postoperatively, patients receive antibiotics and anti-inflammatory medication for one week.
Procedure: Open Reduction and Internal Fixation With Titanium Miniplates
Twelve ml of venous blood is collected into sodium citrate tubes and processed at room temperature by double centrifugation (1200 rpm for 20 minutes, then 2000 rpm for 15 minutes). The platelet-rich fraction is retained and platelet-poor plasma discarded; platelet count and smear are checked. Immediately before use, PRP is activated with calcium chloride and bovine thrombin to form a gel, which is applied once along the fracture line after fixation and before wound closure.
Under general anaesthesia, the fracture is exposed through a vestibular incision, manually reduced, and fixed with two titanium miniplates and screws. The wound is closed with Vicryl sutures. All procedures are performed by the same surgical team.
Bone Density at the Fracture Site
Mean bone density in Hounsfield units (HU) measured on cone-beam computed tomography (CBCT) within a 3 x 2.5 mm rectangular region of interest placed across the fracture line above the upper miniplate, using Planmeca software. Measurements are made by an assessor blinded to group allocation. Higher values indicate greater bone mineralization.
Time frame: 6 months after surgery
Bone Density at the Fracture Site at Early and Intermediate Follow-up
Mean bone density in Hounsfield units measured on CBCT within a 3 x 2.5 mm region of interest across the fracture line above the upper miniplate, using the same method as the primary outcome.
Time frame: 1 week and 3 months after surgery
Bone Density by Fracture Site (Maxilla Versus Mandible)
Mean bone density in Hounsfield units on CBCT at the fracture site, analysed separately for maxillary and mandibular fractures within each group, to compare the effect of platelet-rich plasma between the two fracture sites.
Time frame: 3 months and 6 months after surgery
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Platelet rich plasma
CMH Lahore Medical College and Institute of Dentistry