Osteoradionecrosis of the JawNCT07856875
Platelet-Rich Fibrin for Preventing Osteoradionecrosis After Dental Extractions
A study testing Platelet-rich fibrin (PRF) and Standard Dental Extraction Care in people with Osteoradionecrosis of the Jaw, run by University of Manitoba at 2 sites in Canada.
Trial summary
The goal of this clinical trial is to learn whether platelet-rich fibrin (PRF) can help prevent osteoradionecrosis (ORN) after dental extractions in adults who previously received radiation therapy to the head and neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoradionecrosis of the Jaw
- What is being tested?
- Platelet-rich fibrin (PRF) and Standard Dental Extraction Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2027to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older. History of head and neck cancer treated with radiation therapy. Requires at least one dental extraction within an area of the jaw that was previously treated with radiation.
- Willing and able to attend all study follow-up visits. No minimum or maximum time since completion of radiation therapy is required.
Who cannot join
- Abscess or draining sinus tract associated with a planned study extraction site.
- Blood disorder affecting platelet production or function, such as thrombocytopenia, hemophilia, von Willebrand disease, or a qualitative platelet disorder.
- Current immunosuppressive therapy, including calcineurin inhibitors, antimetabolites, biologic therapy, or active cytotoxic chemotherapy.
- Current tobacco use in any form, including nicotine vaping, within the previous 30 days.
- Known recurrence of head and neck cancer. Previous re-irradiation or re-irradiation currently planned. Chronic systemic corticosteroid use equivalent to at least 5 mg of prednisone daily for at least 30 consecutive days within the previous 3 months.
- Current or previous bisphosphonate therapy by any route. Denosumab within the previous 12 months or use of another antiresorptive or antiangiogenic medication.
- Current pregnancy. Therapeutic low-molecular-weight heparin or unfractionated heparin that cannot be scheduled at trough level.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Arthur J.E. Child Comprehensive Cancer Centre Dental Clinic
Calgary, Alberta, T2N 5G2
Dr. Edmund Chan, DMD, 587-231-5676, edmund.chan@albertahealthservices.ca
Julia Burgess, DMD (Current OMFS Resident), burges16@myumanitoba.ca
Health Sciences Centre Oral Surgery Clinic
Vancouver, British Columbia, V6T 1X4
Julia Burgess, DMD (Current OMFS Resident), 204-787-3645, burges16@myumanitoba.ca
Reda Elgazzar, Oral and Maxillofacial Surgeon, +12047893634, Reda.Elgazzar@umanitoba.ca
About this study
Official title: Multicentre Randomized Controlled Trial Evaluating Platelet-Rich Fibrin (PRF) for the Prevention of Osteoradionecrosis in Patients Requiring Dental Extractions After Radiation Therapy
The goal of this clinical trial is to learn whether platelet-rich fibrin (PRF) can help prevent osteoradionecrosis (ORN) after dental extractions in adults who previously received radiation therapy to the head and neck. ORN is a condition in which jawbone damaged by radiation does not heal properly and may become exposed.
The main question this study aims to answer is:
Read more
Does placing PRF into dental extraction sites lower the chance of developing ORN within 6 months after extraction?
PRF is made from a small sample of a participant's own blood. The blood is processed in a centrifuge to form PRF, which can then be placed into the tooth extraction site.
Researchers will compare participants who receive PRF in addition to standard extraction care with participants who receive standard extraction care alone.
Participants will:
Have one or more teeth removed from an area of the jaw that previously received radiation therapy.
Be randomly assigned to receive either PRF plus standard care or standard care alone.
Return for follow-up visits at approximately 2 weeks, 6 weeks, 3 months, and 6 months after extraction.
Have their healing, pain, any potential postoperative complications, and development of ORN assessed during follow-up.
Read the detailed description
This is a multicentre, randomized controlled trial evaluating platelet-rich fibrin (PRF) for the prevention of osteoradionecrosis (ORN) following dental extraction in adults who have previously received radiation therapy involving the jaws.
Eligible participants requiring extraction of one or more teeth within a previously irradiated field will be randomized in a 1:1 ratio to receive either PRF plus standard extraction care or standard extraction care alone.
For participants allocated to the intervention group, autologous PRF will be prepared chairside from venous blood using horizontal centrifugation and placed into the extraction socket(s) during the same procedure. The PRF will not be stored or transported.
The study will evaluate whether adjunctive PRF reduces the occurrence of ORN following dental extraction and will also evaluate clinical soft-tissue healing, radiographic bone healing, postoperative pain, analgesic use, postoperative complications, and adverse events.
The study will be conducted at participating centres in Winnipeg, Manitoba, and Calgary, Alberta, Canada.
- Conditions
- Osteoradionecrosis of the Jaw
- Being tested
- Platelet-rich fibrin (PRF), Standard Dental Extraction Care
- Keywords
- Osteoradionecrosis, ORN, Platelet-Rich Fibrin, PRF, Dental Extraction, Radiation Therapy, Head and Neck Radiation, Jaw, Post-Radiation Dental Extraction
- Medical subject headings
- Osteoradionecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrin (PRF)Procedure or surgery
Autologous platelet-rich fibrin (PRF) will be prepared chairside from venous blood collected from the participant. Blood will be processed using horizontal centrifugation to produce PRF. The prepared PRF will be placed into the eligible dental extraction socket(s) during the same procedure. PRF will not be stored or transported.
Standard Dental Extraction CareProcedure or surgery
Participants will undergo extraction of one or more eligible teeth within a previously irradiated area of the jaw using standard dental extraction care. No platelet-rich fibrin (PRF) will be placed in the extraction socket(s) as part of this intervention.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Fibrin (PRF) + Standard Care | Experimental | Participants randomized to this arm will undergo dental extraction with standard extraction care and adjunctive placement of autologous platelet-rich fibrin (PRF) into the extraction socket(s). PRF will be prepared chairside from the participant's venous blood using horizontal centrifugation and placed into the extraction socket(s) during the same procedure. Receives: Procedure: Platelet-rich fibrin (PRF); Procedure: Standard Dental Extraction Care |
| Standard Care Alone | Active comparator | Participants randomized to this arm will undergo dental extraction with standard extraction care without placement of platelet-rich fibrin (PRF) into the extraction socket(s). Receives: Procedure: Standard Dental Extraction Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Osteoradionecrosis Within 6 Months
Osteoradionecrosis (ORN) will be assessed at the participant level using the ClinRad definition adopted by the ISOO-MASCC-ASCO guideline. ORN is defined as a radiographic lytic or mixed sclerotic lesion of bone, visibly exposed bone, and/or bone probeable through a periodontal pocket or fistula within an anatomical site previously exposed to therapeutic head and neck radiation. A participant will meet the primary endpoint if at least one study extraction socket meets the definition at any scheduled or unscheduled visit through 6 months.
Measured: From dental extraction through 6 months after extraction
Secondary outcomes (3)
Complete Mucosal Closure of the Extraction Site
Complete mucosal closure will be assessed clinically at each study extraction socket and recorded as a binary outcome (yes/no). Complete mucosal closure is defined as intact epithelium across the entire socket orifice, with no dehiscence and no exposed bone. Socket-level outcomes will account for clustering of multiple extraction sockets within individual participants.
Measured: 2 weeks, 6 weeks, 3 months, and 6 months after dental extraction
Radiographic Bone Healing at the Extraction Site
Radiographic bone healing at each study extraction site will be assessed by qualitative comparison of the 6-month cone-beam computed tomography (CBCT) scan with the pre-extraction baseline CBCT. Assessment will include the presence, absence, and extent of lytic or mixed sclerotic changes and cortical continuity at the socket crest.
Measured: Baseline to 6 months after dental extraction
Postoperative Pain Intensity
Pain intensity at each study extraction socket will be assessed using the 11-point Numeric Rating Scale (NRS-11), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Participants will rate pain at each extraction site over the preceding 24 hours. Higher scores indicate greater pain intensity.
Measured: 2 weeks, 6 weeks, 3 months, and 6 months after dental extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 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.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reda Elgazzar, University of Manitoba
- Investigators
- Julia M Burgess, DMD (current OMFS Resident), Principal investigator, University of ManitobaReda Elgazzar, Oral and Maxillofacial Surgeon, Study director, University of ManitobaEdmund Chan, DMD, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856875
- Sponsor's protocol ID
- PRF-ORN-RCT-2026
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Oct 2026
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Controlled Trial Evaluating Platelet-Rich Fibrin (PRF) for the Prevention of Osteoradionecrosis in Patients Requiring Dental Extractions After Radiation Therapy
- ClinicalTrials.gov ID
- NCT07856875
- Acronym / sponsor ID
- PRF-ORN-RCT-2026
- Conditions
- Osteoradionecrosis of the Jaw
- Keywords
- Osteoradionecrosis, ORN, Platelet-Rich Fibrin, PRF, Dental Extraction, Radiation Therapy, Head and Neck Radiation, Jaw
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Oct 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.
The goal of this clinical trial is to learn whether platelet-rich fibrin (PRF) can help prevent osteoradionecrosis (ORN) after dental extractions in adults who previously received radiation therapy to the head and neck. ORN is a condition in which jawbone damaged by radiation does not heal properly and may become exposed.
The main question this study aims to answer is:
Does placing PRF into dental extraction sites lower the chance of developing ORN within 6 months after extraction?
PRF is made from a small sample of a participant's own blood. The blood is processed in a centrifuge to form PRF, which can then be placed into the tooth extraction site.
Researchers will compare participants who receive PRF in addition to standard extraction care with participants who receive standard extraction care alone.
Participants will:
Have one or more teeth removed from an area of the jaw that previously received radiation therapy.
Be randomly assigned to receive either PRF plus standard care or standard care alone.
Return for follow-up visits at approximately 2 weeks, 6 weeks, 3 months, and 6 months after extraction.
Have their healing, pain, any potential postoperative complications, and development of ORN assessed during follow-up.
Detailed description
This is a multicentre, randomized controlled trial evaluating platelet-rich fibrin (PRF) for the prevention of osteoradionecrosis (ORN) following dental extraction in adults who have previously received radiation therapy involving the jaws.
Eligible participants requiring extraction of one or more teeth within a previously irradiated field will be randomized in a 1:1 ratio to receive either PRF plus standard extraction care or standard extraction care alone.
For participants allocated to the intervention group, autologous PRF will be prepared chairside from venous blood using horizontal centrifugation and placed into the extraction socket(s) during the same procedure. The PRF will not be stored or transported.
The study will evaluate whether adjunctive PRF reduces the occurrence of ORN following dental extraction and will also evaluate clinical soft-tissue healing, radiographic bone healing, postoperative pain, analgesic use, postoperative complications, and adverse events.
The study will be conducted at participating centres in Winnipeg, Manitoba, and Calgary, Alberta, Canada.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Fibrin (PRF) + Standard Care | Experimental | Procedure: Platelet-rich fibrin (PRF), Procedure: Standard Dental Extraction CareParticipants randomized to this arm will undergo dental extraction with standard extraction care and adjunctive placement of autologous platelet-rich fibrin (PRF) into the extraction socket(s). PRF will be prepared chairside from the participant's venous blood using horizontal centrifugation and placed into the extraction socket(s) during the same procedure. |
| Standard Care Alone | Active comparator | Procedure: Standard Dental Extraction CareParticipants randomized to this arm will undergo dental extraction with standard extraction care without placement of platelet-rich fibrin (PRF) into the extraction socket(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older. History of head and neck cancer treated with radiation therapy. Requires at least one dental extraction within an area of the jaw that was previously treated with radiation.
- Willing and able to attend all study follow-up visits. No minimum or maximum time since completion of radiation therapy is required.
Key exclusion criteria (7 listed)
- Abscess or draining sinus tract associated with a planned study extraction site.
- Blood disorder affecting platelet production or function, such as thrombocytopenia, hemophilia, von Willebrand disease, or a qualitative platelet disorder.
- Current immunosuppressive therapy, including calcineurin inhibitors, antimetabolites, biologic therapy, or active cytotoxic chemotherapy.
- Current tobacco use in any form, including nicotine vaping, within the previous 30 days.
- Known recurrence of head and neck cancer. Previous re-irradiation or re-irradiation currently planned. Chronic systemic corticosteroid use equivalent to at least 5 mg of prednisone daily for at least 30 consecutive days within the previous 3 months.
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 |
|---|---|---|
| Platelet-rich fibrin (PRF)Autologous platelet-rich fibrin (PRF) will be prepared chairside from venous blood collected from the participant. Blood will be processed using horizontal centrifugation to produce PRF. The prepared PRF will be placed into the eligible dental extraction socket(s) during the same procedure. PRF will not be stored or transported. | Procedure or surgery | Platelet-Rich Fibrin (PRF) + Standard Care |
| Standard Dental Extraction CareParticipants will undergo extraction of one or more eligible teeth within a previously irradiated area of the jaw using standard dental extraction care. No platelet-rich fibrin (PRF) will be placed in the extraction socket(s) as part of this intervention. | Procedure or surgery | Platelet-Rich Fibrin (PRF) + Standard Care, Standard Care Alone |
Primary outcome
Incidence of Osteoradionecrosis Within 6 Months
Time frame: From dental extraction through 6 months after extraction
Osteoradionecrosis (ORN) will be assessed at the participant level using the ClinRad definition adopted by the ISOO-MASCC-ASCO guideline. ORN is defined as a radiographic lytic or mixed sclerotic lesion of bone, visibly exposed bone, and/or bone probeable through a periodontal pocket or fistula within an anatomical site previously exposed to therapeutic head and neck radiation. A participant will meet the primary endpoint if at least one study extraction socket meets the definition at any scheduled or unscheduled visit through 6 months.
3 secondary outcomes
Complete Mucosal Closure of the Extraction Site
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months after dental extraction
Radiographic Bone Healing at the Extraction Site
Time frame: Baseline to 6 months after dental extraction
Postoperative Pain Intensity
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months after dental 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 5 Oct 2026.
- Individual participant dataSharing planned: No
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L-PRF in Prevention of ORN and MRONJ Following Tooth Extractions;v3.0
Osteoradionecrosis of the Jaw, Medicine Related Osteonecrosis of the Jaw
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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.
Julia M Burgess, DMD (current OMFS Resident) principal investigator
University of Manitoba
Reda Elgazzar, Oral and Maxillofacial Surgeon study director
University of Manitoba
Edmund Chan, DMD study director
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich fibrin (PRF) and Standard Dental Extraction Care in people with Osteoradionecrosis of the Jaw, run by University of Manitoba at 2 sites in Canada.
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 2 inclusion and 7 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
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 Julia M Burgess, DMD (current OMFS Resident) (6042206648, burges16@myumanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Osteoradionecrosis Within 6 Months (time frame: From dental extraction through 6 months after extraction). 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 5 Oct 2026.