Osteoradionecrosis of the JawNCT07585123
L-PRF in Prevention of ORN and MRONJ Following Tooth Extractions;v3.0
A study testing L-PRF and Standard Extraction in people with Osteoradionecrosis of the Jaw and Medicine Related Osteonecrosis of the Jaw, run by Swansea Bay University Health Board at 1 site in United Kingdom.
Trial summary
Osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ) are debilitating complications following dental extractions in patients who have received head and neck radiotherapy or antiresorptive therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoradionecrosis of the Jaw, Medicine Related Osteonecrosis of the Jaw
- What is being tested?
- L-PRF and Standard Extraction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -General Inclusion Criteria (Applies to All Participants)
- Age ≥18 years
- Requiring extraction of one or more teeth with hopeless prognosis
- Capacity to provide informed consent
- Ability and willingness to attend all scheduled follow-up visits over 12 months
- -Post-Radiotherapy Group - Specific Inclusion
Show all 12Show fewer
- Previous radiotherapy to the head and neck region
- Documented radiation dose ≥50 Gy
- Radiotherapy records (dose, field, date) must be available
- -Antiresorptive Group - Specific Inclusion
- Current or prior use of antiresorptive agents (e.g. bisphosphonates or denosumab)
- Medication history must be available in medical records
Who cannot join
- General Exclusion Criteria (Applies to All Participants)
- Inability to maintain adequate oral hygiene due to motor disability
- Uncontrolled systemic illness (e.g. uncontrolled diabetes)
- Use of anticoagulants, immunosuppressants, or medications known to impair healing
- Requirement for surgical (complex) extractions
- Enrolment in another clinical trial
Show all 15Show fewer
- Known allergy to anaesthetic agents, L-PRF components, or antibiotics used in perioperative protocol
- Anticipated non-compliance with follow-up
- -Post-Radiotherapy Group - Specific Exclusion
- Previous or current antiresorptive therapy
- History of re-irradiation or radiation dose <50 Gy
- -Antiresorptive Group - Specific Exclusion
- History of head and neck radiotherapy
- Neoplastic involvement of the jaws
- Active untreated oral infection or pathology at time of planned extraction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Morriston Hospital
Swansea, SA6 6NL
Partha S Chakraborty, +44 7867063718, Partha.Chakraborty@wales.nhs.uk
Partha S Chakraborty
About this study
Official title: Role of Platelet-Rich Fibrin in the Prevention of Osteoradionecrosis and Medication-related Osteonecrosis of the Jaw Following Tooth Extractions: A Prospective, Triple-Blind, Randomised Feasibility Trial
Osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ) are debilitating complications following dental extractions in patients who have received head and neck radiotherapy or antiresorptive therapy. These conditions are associated with significant morbidity, including persistent pain, poor oral function, and reduced quality of life.
While preventive strategies remain limited, platelet-rich fibrin (L-PRF), an autologous fibrin matrix enriched with growth factors, has shown potential in promoting wound healing and modulating inflammation. This prospective, triple-blind, randomised pilot trial aims to evaluate the effectiveness of L-PRF in enhancing socket healing and reducing the incidence of ORN and MRONJ. Forty patients (20 post-radiotherapy, 20 on antiresorptive agents) undergoing non-surgical dental extractions will be randomised to receive either L-PRF or standard care. The primary outcome is mucosal healing at Day 10 post-extraction, assessed using the Landry wound healing index. Secondary outcomes include the incidence of ORN or MRONJ at extraction sites assessed at 9, 17, 25, and 52 weeks. This study aims to provide early evidence on the clinical utility of L-PRF in preventing osteonecrosis in high-risk patients.
Read the detailed description
Osteoradionecrosis (ORN) is a condition in which necrosis of the jawbone occurs in patients who have previously undergone radiotherapy for head and neck cancer. Medication-Related Osteonecrosis of the Jaw (MRONJ) occurs in patients receiving, or who have received, antiresorptive therapies such as bisphosphonates or denosumab. Both conditions share underlying mechanisms including impaired bone healing, chronic inflammation, and disrupted angiogenesis . Patients in either group face an increased risk of poor healing following tooth extraction, which can result in persistent pain, infection, and progressive jawbone necrosis. These complications profoundly impair patients' abilities to eat and speak, significantly reducing their quality of life.
ORN and MRONJ are extremely difficult to predict, prevent, and manage. Treatment typically requires removal of necrosed bone followed by complex reconstructive procedures that consume significant hospital resources, including materials, staff time, and prolonged hospital stays. Despite these interventions, patients often experience substantial reductions in quality of life. The economic burden on the NHS and responsible trusts is considerable, underscoring the urgent need for improved preventive approaches.
Leukocyte- and platelet- rich fibrin (L-PRF), an autologous leukocyte and platelet concentrate, has demonstrated promising results in promoting soft tissue and bone healing, owing to its angiogenic, anti-inflammatory, and regenerative properties . Its use in dental extractions could mitigate the risk of developing ORN or MRONJ in high-risk populations.
L-PRF is a second-generation platelet concentrate that releases growth factors such as PDGF, TGF-β, and VEGF over an extended period. In vitro studies show that its three-dimensional fibrin matrix continuously releases these factors and cytokines for up to 21 days, which helps regulate inflammation and promote angiogenesis, supporting tissue healing.
L-PRF, a second-generation platelet concentrate, has gained popularity in oral surgery and periodontal procedures (12) with evidence suggesting faster mucosal healing and reduced post-operative complications, because of a slower, continuous release of growth factors when compared to other concentrates in vitro. Furthermore, the leukocytes presented in L-PRF may synthesize several pro- and anti-inflammatory cytokines as well.
However, controlled data on its use specifically for ORN or MRONJ prevention is scarce. Small case series and observational studies suggest improved outcomes, but robust trial data is lacking.
Given the significant morbidity associated with ORN and MRONJ and the lack of proven preventive strategies, evaluating L-PRF in a clinical trial setting is justified. The intervention is autologous and low-risk. Potential benefits include enhanced mucosal healing and reduced incidence of osteonecrosis. Risks are minimal and largely relate to venepuncture or standard surgical procedures. The trial aims to determine feasibility, safety, and early efficacy signals to inform future large-scale trials.
- Being tested
- L-PRF, Standard Extraction
- Keywords
- L-PRF, ORN, MRONJ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRFOther
L-PRF is made from the patient's own blood and contains natural healing cells and growth factors. It is already used in other areas of dentistry to help wounds heal, but it is not yet clear whether it helps prevent jawbone necrosis in patients with a history of radiotherapy for head and cancers, or in patients taking antiresorptive medications. This study will help us understand whether using L-PRF during extractions makes healing faster and safer and can can prevent or reduce the chance of developing osteoradionecrosis or MRONJ in patients with a history of radiotherapy for head and cancers, or in patients taking antiresorptive medications respectively.
Standard ExtractionOther
No L-PRF will be placed in the post-extraction sockets
| Study group | Role | What they receive |
|---|---|---|
| L-PRF Group: Tooth socket will be treated with Platelet-Rich Fibrin (L-PRF) | Experimental | Not described Receives: Other: L-PRF |
| Control Group | Placebo comparator | Not described Receives: Other: Standard Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal healing of the dental extraction, assessed using the Landry Wound Healing Index.
Measured: Day !0
Secondary outcomes (1)
Incidence of ORN and MRONJ at the extraction sites
Measured: assessed at 9, 17, 25 weeks and 12 months post-extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start2 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoradionecrosis of the JawStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea Bay University Health Board
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketan R Shah, FRCS, Study chair, Swansea Bay University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585123
- Sponsor's protocol ID
- SBU62
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Platelet-Rich Fibrin in the Prevention of Osteoradionecrosis and Medication-related Osteonecrosis of the Jaw Following Tooth Extractions: A Prospective, Triple-Blind, Randomised Feasibility Trial
- ClinicalTrials.gov ID
- NCT07585123
- Acronym / sponsor ID
- SBU62
- Keywords
- L-PRF, ORN, MRONJ
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Swansea Bay University Health BoardUniversity, hospital or other
- Study start
- 2 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 13 May 2026 (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.
Osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ) are debilitating complications following dental extractions in patients who have received head and neck radiotherapy or antiresorptive therapy. These conditions are associated with significant morbidity, including persistent pain, poor oral function, and reduced quality of life.
While preventive strategies remain limited, platelet-rich fibrin (L-PRF), an autologous fibrin matrix enriched with growth factors, has shown potential in promoting wound healing and modulating inflammation. This prospective, triple-blind, randomised pilot trial aims to evaluate the effectiveness of L-PRF in enhancing socket healing and reducing the incidence of ORN and MRONJ. Forty patients (20 post-radiotherapy, 20 on antiresorptive agents) undergoing non-surgical dental extractions will be randomised to receive either L-PRF or standard care. The primary outcome is mucosal healing at Day 10 post-extraction, assessed using the Landry wound healing index. Secondary outcomes include the incidence of ORN or MRONJ at extraction sites assessed at 9, 17, 25, and 52 weeks. This study aims to provide early evidence on the clinical utility of L-PRF in preventing osteonecrosis in high-risk patients.
Detailed description
Osteoradionecrosis (ORN) is a condition in which necrosis of the jawbone occurs in patients who have previously undergone radiotherapy for head and neck cancer. Medication-Related Osteonecrosis of the Jaw (MRONJ) occurs in patients receiving, or who have received, antiresorptive therapies such as bisphosphonates or denosumab. Both conditions share underlying mechanisms including impaired bone healing, chronic inflammation, and disrupted angiogenesis . Patients in either group face an increased risk of poor healing following tooth extraction, which can result in persistent pain, infection, and progressive jawbone necrosis. These complications profoundly impair patients' abilities to eat and speak, significantly reducing their quality of life.
ORN and MRONJ are extremely difficult to predict, prevent, and manage. Treatment typically requires removal of necrosed bone followed by complex reconstructive procedures that consume significant hospital resources, including materials, staff time, and prolonged hospital stays. Despite these interventions, patients often experience substantial reductions in quality of life. The economic burden on the NHS and responsible trusts is considerable, underscoring the urgent need for improved preventive approaches.
Leukocyte- and platelet- rich fibrin (L-PRF), an autologous leukocyte and platelet concentrate, has demonstrated promising results in promoting soft tissue and bone healing, owing to its angiogenic, anti-inflammatory, and regenerative properties . Its use in dental extractions could mitigate the risk of developing ORN or MRONJ in high-risk populations.
L-PRF is a second-generation platelet concentrate that releases growth factors such as PDGF, TGF-β, and VEGF over an extended period. In vitro studies show that its three-dimensional fibrin matrix continuously releases these factors and cytokines for up to 21 days, which helps regulate inflammation and promote angiogenesis, supporting tissue healing.
L-PRF, a second-generation platelet concentrate, has gained popularity in oral surgery and periodontal procedures (12) with evidence suggesting faster mucosal healing and reduced post-operative complications, because of a slower, continuous release of growth factors when compared to other concentrates in vitro. Furthermore, the leukocytes presented in L-PRF may synthesize several pro- and anti-inflammatory cytokines as well.
However, controlled data on its use specifically for ORN or MRONJ prevention is scarce. Small case series and observational studies suggest improved outcomes, but robust trial data is lacking.
Given the significant morbidity associated with ORN and MRONJ and the lack of proven preventive strategies, evaluating L-PRF in a clinical trial setting is justified. The intervention is autologous and low-risk. Potential benefits include enhanced mucosal healing and reduced incidence of osteonecrosis. Risks are minimal and largely relate to venepuncture or standard surgical procedures. The trial aims to determine feasibility, safety, and early efficacy signals to inform future large-scale trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-PRF Group: Tooth socket will be treated with Platelet-Rich Fibrin (L-PRF) | Experimental | Other: L-PRF |
| Control Group | Placebo comparator | Other: Standard Extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -General Inclusion Criteria (Applies to All Participants)
- Age ≥18 years
- Requiring extraction of one or more teeth with hopeless prognosis
- Capacity to provide informed consent
- Ability and willingness to attend all scheduled follow-up visits over 12 months
Key exclusion criteria (15 listed)
- General Exclusion Criteria (Applies to All Participants)
- Inability to maintain adequate oral hygiene due to motor disability
- Uncontrolled systemic illness (e.g. uncontrolled diabetes)
- Use of anticoagulants, immunosuppressants, or medications known to impair healing
- Requirement for surgical (complex) extractions
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 |
|---|---|---|
| L-PRFL-PRF is made from the patient's own blood and contains natural healing cells and growth factors. It is already used in other areas of dentistry to help wounds heal, but it is not yet clear whether it helps prevent jawbone necrosis in patients with a history of radiotherapy for head and cancers, or in patients taking antiresorptive medications. This study will help us understand whether using L-PRF during extractions makes healing faster and safer and can can prevent or reduce the chance of developing osteoradionecrosis or MRONJ in patients with a history of radiotherapy for head and cancers, or in patients taking antiresorptive medications respectively. | Other | L-PRF Group: Tooth socket will be treated with Platelet-Rich Fibrin (L-PRF) |
| Standard ExtractionNo L-PRF will be placed in the post-extraction sockets | Other | Control Group |
Primary outcome
Mucosal healing of the dental extraction, assessed using the Landry Wound Healing Index.
Time frame: Day !0
1 secondary outcome
Incidence of ORN and MRONJ at the extraction sites
Time frame: assessed at 9, 17, 25 weeks and 12 months post-extraction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoradionecrosis of the Jaw
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Platelet-Rich Fibrin for Preventing Osteoradionecrosis After Dental Extractions
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Impacted Tooth Management and Osteoradionecrosis Risk in NPC
Nasopharyngeal Carcinoma (NPC), Osteoradionecrosis of the Jaw
RecruitingPhase 3
Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible
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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.
Ketan R Shah, FRCS study chair
Swansea Bay University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-PRF and Standard Extraction in people with Osteoradionecrosis of the Jaw and Medicine Related Osteonecrosis of the Jaw, run by Swansea Bay University Health Board at 1 site in United Kingdom.
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 12 inclusion and 15 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: opening soon, as of the sponsor's last update on 13 May 2026. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Partha S Chakraborty (+44 7867063718, Partha.Chakraborty@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal healing of the dental extraction, assessed using the Landry Wound Healing Index. (time frame: Day !0). 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 13 May 2026.