This study is going to be performed on patients afferent to the service of Chirurgia Maxillo Facciale dell’Ospedale Maggiore della Carita` di Novara subject to eights bony included extraction. MedDRA version: 9.1 Level: SOC Classification code 10042613
Conditions
Interventions
Trade Name: SOLDESAM
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Dexamethasone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Trade Name: S
Sponsors
AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients anti-edema therapy with systemic intravenous corticosteroids administered. 2. patients anti-edema therapy with systemic oral corticosteroids administered. 3. patients anti-edema therapy with local corticosteroids Are the trial subjects under 18? yes 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: Presence of acute oral pathology (periodontitis, perichondropathy, abscesses, mucositis etc..), Chronic oral pathology causing flogosis, Patients treated for acute oral pathology (abscesses) till 2 weeks from regression of the event or non regressing by 1? level medical therapy (oral antibiotic therapy), Post-operative local complications and/or extension of hospitalization for any reason, Systemic patholgies: • severe internistic pathologies (systemic infectious deseases, cardiovascular patholgies, liver deseases, hemopathies, coagulation deficiency, diabetes, cancer), or pre-hospitalization blood exams altered ( ex. Creatinine > 1.5mg/dl), • recent anti-nflammatory therapy • chronic use of such drugs may alter inflammatory response (antihistamines, steroids, antidepressants, NSAIDS), Pregnancy and nursing, Surgical procedures total time: all the patients surgically treated over 60’ minutes have been excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to value if exist or no any benefit by using corticosteroid therapy in decreasing postoperative pain after extraction of eights teeth (systemic VS local VS oral somministration).;Secondary Objective: Then we want to verify if any similar therapeutical effect using the same drug by a different administration exists, and if this differenceis statistically significative.;Primary end point(s): Finally we wan to test if both two way of administration are different related to face edema, mouth opening, and pain. | — |
Countries
Italy
Outcome results
None listed