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Clinical Trials/EUCTR2010-019060-37-IT
EUCTR2010-019060-37-IT
Active, Not Recruiting
N/A

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

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 sitesJuly 13, 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Status
Active, Not Recruiting
Last Updated
12 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 13, 2010
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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