Efficacy and Safety of Wobenzym® as Antiedematous Therapy In Dentosurgical Operations
Placebo Controlled Double Blind Clinical Trial
Integrated Medical-Biometric Final Report
Investigator: Univ.-Doz. Kurt Vinzenz, M.D.
Clinic for Oral Surgery and Plastic Surgery of the Face, University of Vienna, General HospitaI Vienna, Alserstrasse 4, A-1090 Vienna, Austria
Evaluation by: MUCOS Pharma GmbH & Co, Dept. Clinical Research, Alpenstrasse 29, D-8192 Geretsried 1, F.R.G.
Summary
In a randomised double blind trial the efficacy and tolerance of perioperatively given WOBENZYM® was proved as an antiedematous drug for treatment of edema after dentosurgical operations. 80 patients were included into the trial. 36 of these patients received WOBENZYM® and 44 patients placebo.
The efficacy of WOBENZYM® was judged by the physician in 88.9% of all cases as "very good" or "good" and only in two cases as "moderate". The mean value was 1.5 ("very good" to "good").
In the placebo group the result of the therapy was judged by the physician only in 56.8% of all cases as "very good" or "good" and in 40.9% as "moderate" or "poor"; the mean value was 2.2 ("good").
The tolerance of the therapy was judged in the WOBENZYM® group and in the placebo group on average as 1.0 ("very good").
Adverse reactions were noted in two patients of the WOBENZYM® group: one patient had diarrhea and meteorism and one patient had diarrhea. The degree of severity of the adverse reaction was in each case slight or moderate. A third adverse reaction was documented, but the physician did not connect the adverse reaction with WOBENZYM®.
In the WOBENZYM® group the peak concentrations of the laboratory values pointing out inflammatory processes (haptoglobin, C-reactive protein, erythrocyte sedimentation rate) were lower than in the placebo group. The ESR was tested statistically: the difference was significant.
The mouth opening (distance between the upper and the lower central incisor) after surgery in the WOBENZYM® group was statistically significantly less handicapped than in the placebo group.
Statistical significance was also computed for a quicker normalization of the deviation of median line and a faster reduction of the lobe thickness in the WOBENZYM® group. Also the reduction of dysphagia of palpable and painful enlarged lymph nodes and the course of the wound healing showed a significant advantage in favour of the WOBENZYM® therapy.
WOBENZYM® showed to be an excellent drug in prevention of edema after tooth extraction. WOBENZYM® reduced clearly the postoperative symptoms and inflammatory processes.