Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study

Osteoradionecrosis of Jaw Clinical Trial

— OPEN  

Official title:

Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097847
• Other study ID #: OPEN (29BRC17.0115)
• Status: Completed
• Start date: June 2, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

osteoradionecrosis (ORN) affects up to 30% of irradiated patients and can occur up to several decades after stopping treatment. Differents therapeutics exist but there is no consensus concerning the management of the maxillary ORN. The understanding of new pathological mechanisms opens the way to new therapeutic perspectives.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 being or having been treated by pentoclo combination for an osteoradionecrosis of the jaw

Exclusion Criteria:

• Tumoral recidivism

• Precocious stop of pentoclo

Related Conditions & MeSH terms

• Osteoradionecrosis
• Osteoradionecrosis of Jaw

Intervention

Drug:
• Pentoxifylline-Tocopherol-Clodronate
the aim of this retrospective study is to analyze from patient records the impact of the PENTOCLO protocol on maxillofacial osteoradionecrosis at Brest Hospital University, France.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evolution of the osteoradionecrosis lesion after introducing PENTOCLO protocol	Retrospective study based on recovering patient data from medical records	2 years