- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07585123
L-PRF in Prevention of ORN and MRONJ Following Tooth Extractions;v3.0
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Partha S Chakraborty
- Telefonní číslo: +44 7867063718
- E-mail: Partha.Chakraborty@wales.nhs.uk
Studijní místa
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Swansea, Spojené království, SA6 6NL
- Morriston Hospital
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Kontakt:
- Partha S Chakraborty
- Telefonní číslo: +44 7867063718
- E-mail: Partha.Chakraborty@wales.nhs.uk
-
Vrchní vyšetřovatel:
- Partha S Chakraborty
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
-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
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
Exclusion Criteria:
- 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
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Komparátor placeba: Kontrolní skupina
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No L-PRF will be placed in the post-extraction sockets
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Experimentální: L-PRF Group: Tooth socket will be treated with Platelet-Rich Fibrin (L-PRF)
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Mucosal healing of the dental extraction, assessed using the Landry Wound Healing Index.
Časové okno: Day !0
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Day !0
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Incidence of ORN and MRONJ at the extraction sites
Časové okno: assessed at 9, 17, 25 weeks and 12 months post-extraction.
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assessed at 9, 17, 25 weeks and 12 months post-extraction.
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Ketan R Shah, FRCS, Swansea Bay University Health Board
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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