L-PRF in Prevention of ORN and MRONJ Following Tooth Extractions;v3.0

NCT07585123 | Not Yet Recruiting DMC

• 1 other identifier: SBU62
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteoradionecrosis of the Jaw; Medicine Related Osteonecrosis of the Jaw

Keywords

L-PRF, ORN, MRONJ

Outcome Measures

Primary Outcomes (1)

• Mucosal healing of the dental extraction, assessed using the Landry Wound Healing Index.

  Day !0

Secondary Outcomes (1)

• Incidence of ORN and MRONJ at the extraction sites

  assessed at 9, 17, 25 weeks and 12 months post-extraction.

Study Arms (2)

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

Interventions

L-PRF OTHER

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.

L-PRF Group: Tooth socket will be treated with Platelet-Rich Fibrin (L-PRF)

Standard Extraction OTHER

No L-PRF will be placed in the post-extraction sockets

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Previous radiotherapy to the head and neck region
• Documented radiation dose ≥50 Gy
• Radiotherapy records (dose, field, date) must be available
• Current or prior use of antiresorptive agents (e.g. bisphosphonates or denosumab)
• Medication history must be available in medical records

You may not qualify if:

• 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
• Known allergy to anaesthetic agents, L-PRF components, or antibiotics used in perioperative protocol
• Anticipated non-compliance with follow-up
• Previous or current antiresorptive therapy
• History of re-irradiation or radiation dose \<50 Gy
• History of head and neck radiotherapy
• Neoplastic involvement of the jaws
• Active untreated oral infection or pathology at time of planned extraction

Sponsors & Collaborators

• Swansea Bay University Health Board: lead

Study Sites (1)

Morriston Hospital

Swansea, SA6 6NL, United Kingdom

Location

Study Officials

• Ketan R Shah, FRCS

  Swansea Bay University Health Board

  STUDY CHAIR

Central Study Contacts

Partha S Chakraborty

CONTACT

+44 7867063718; Partha.Chakraborty@wales.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): August 2, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

GB (1)