Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw
Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw: a Multicenter, Randomized, Clinical Trial
Medication related Osteonecrosis of the Jaw (MRONJ) consists of progressive destruction of bone in the maxillofacial area. It is an established complication which occurs in patients who take two main classes of antiresorptive drugs: Bisphosphonates (BP) and Denosumab.
PRGF is a autologous platelet-enriched plasma obtained from the patient's own blood. It contains proteins that can influence and promote cell recruitment and its beneficial effect could consist in improving bone and soft tissue healing. These benefits are likely to apply to MRONJ surgery, as it is suggested by small retrospective or prospective case series.
This is a randomized, multi center study comparing the outcomes of surgery alone and PRGF plus surgery in patients requiring surgical treatment for MRONJ.
To assess the superiority of surgery plus PRGF compared to surgery alone in patients treated for MRONJ. Primary endpoint for this scope is a composite of clinical or radiological recurrence rate of disease during a 12 months post-operative period.
Secondary endpoints are: a) morbidity, defined as nerve injury, bleeding, vascular or wound complications. b) post- and peri-operative pain defined by the treated subjects according to a standardized VAS score c) quality of life (QoL) defined by a standardized scale.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Subjects must be candidates for surgical treatment for MRONJ at stage 2 or 3.
- Subjects must be >18 and <80 years of age
- Subjects must sign a informed consent prior to randomization and must agree to return to scheduled follow-up visits
Exclusion Criteria:
- Subject has inability to understand and cooperate with the study procedures or provide informed consent
- Subject has bleeding diathesis or coaugolapthy, or will refuse autologous blood sampling
- Subject had a cardiovascular event in the past 30 days
- Subject has any condition that limits their anticipated survival to less than 3 months
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: surgery only
Surgery consisting in debridement/removal of affected tissue/s will be performed.
|
surgery without the use of prgf
|
|
Aktiv komparator: surgery and PRGF
Surgery consisting in debridement/removal of affected tissue/s will be performed.
Platelet Rich Growth Factor (device) will be produced by a venous blood sampling of the patient and applied to the treated area
|
surgery and application of PRGF
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
recurrence of disease
Tidsram: 12 months
|
clinical or radiological recurrence rate of disease during a 12 months post-operative period
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
morbidity
Tidsram: 12 months
|
nerve injury, bleeding, vascular or wound complications
|
12 months
|
|
post- and peri-operative pain
Tidsram: 1 week
|
defined by the treated subjects according to a standardized Visual Analog Scale (VAS) score which will be used to define the pain in this way: the patient will assign a value to the experienced pain that goes from 0 no pain to 10 the worst pain the patient can imagine.
|
1 week
|
|
quality of life (QoL)
Tidsram: 12 months
|
defined by a standardized scale developed by the who and whose details can be on the who website http://www.who.int/mental_health/publications/whoqol/en/
|
12 months
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 26122017
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
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