Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw

Osteonecrosis Due to Drugs, Jaw Clinical Trial

Official title:

Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw: a Multicenter, Randomized, Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03390777
• Other study ID #: 26122017
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: December 26, 2017
• Last updated: January 4, 2018
• Start date: September 2018
• Est. completion date: January 2022

Study information

• Verified date: January 2018
• Source: University of Roma La Sapienza
• Contact: Oreste Iocca, D.D.S., M.D.
• Phone: 0039 3398540122
• Email: oi243[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteonecrosis
• Osteonecrosis Due to Drugs, Jaw

Intervention

Procedure:
• surgery
surgery without the use of prgf

Device:
• PRGF after surgery
surgery and application of PRGF

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Roma La Sapienza	NYU College of Dentistry, Universidade da Coruña

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of disease	clinical or radiological recurrence rate of disease during a 12 months post-operative period	12 months
Secondary	morbidity	nerve injury, bleeding, vascular or wound complications	12 months
Secondary	post- and peri-operative pain	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
Secondary	quality of life (QoL)	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