patients affected by bisphosponate-associated osteonecrosis of the jaws and infection. MedDRA version: 9.1 Level: LLT Classification code 10031264 MedDRA version: 9.1 Level: LLT Classification code 10021864
Conditions
Interventions
Trade Name: FLAGYL
Pharmaceutical Form: Tablet
INN or Proposed INN: Metronidazole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Trade Name: CLAVULIN
Pharmac
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the long-term efficacy of a hygienical protocol (scaling and alternation of chlorexidine and essential oils mouth washes) combined with metronidazole (two 250-mg tablets every 12 hours for ten days, extendable or repeatable in case of persistence or reprisal of the symptoms) in addition to antibiotic therapy: amoxicillin + clavulanic acid (one 1-g tablet every 8 hours for two days, then one 1-g tablet every 12 hours for eight days, extendable or repeatable in case of persistence or reprisal of the symptoms) or ciprofloxacin (one 750-mg tablets every 12 hours for ten days, extendable or repeatable in case of persistence or reprisal of the symptoms; therapy used in patients allergic to penicillins) in ensuring a good quality of life in patients affected by bisphosphonate-associated osteonecrosis of the jaws.;Secondary Objective: ;Primary end point(s): The evaluation of the efficacy of the present protocol will be made on the behalf of its capability in mantaining the patient in a state of good health, definable in: no pain or low pain level (VAS less than 3), no edema, no purulent exudate, no report of difficulties in phonation or chewing (excluding problems resulting from the patient s dental condition), no gingivitis nor periodontitis, no worsening of the lesions in dimensional terms (no changes in the largest diameter of the lesion) or formation of a bone sequestration and reduction of the lesion size (reduction of the largest diameter of the lesion), periodontal pockets unchanged or reduced (less than 4 mm). | — |
Countries
Italy
Outcome results
None listed