Clinical prospective study to evaluate the efficacy of hygienical therapy and metronidazole in addition to antibiotic therapy in patients affected by bisphosponate-associated osteonecrosis of the jaws - CH.MAX-FACC.02/2009

• Conditions: patients affected by bisphosponate-associated osteonecrosis of the jaws and infection.; MedDRA version: 9.1Level: LLTClassification code 10031264; MedDRA version: 9.1Level: LLTClassification code 10021864

• Registration Number: EUCTR2010-019060-37-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-13
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with a history of present or previous (interrupted within 10 years) bisphosphonate therapy and diagnosis of osteonecrosis of the jaws. Males or females. Adult patients (more than 18 years old) Patients without pathologies which contraindicate the antibiotic therapy. Patients who have signed the informed consent. Patients who can understand the conditions of the present study and participate for its whole duration.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Poor compliance to oral hygiene after experimenter s motivation. Patients affected by patologies who contraindicate the antibiotic therapy. Patients who cannot follow the hygienical procedures indicated in the present protocol nor sign the informed consent. Not-collaborating patients. Known or suspected hypersensitivity towards the drug or the drug class studied. Patients affected by severe clinical conditions which, in experimenter s opinion, contraindicate their participation in the present study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified