A prospective, randomized, observer-blind, reference-controlled (Provicol ®) Phase III clinical study on the efficacy and safety of Ledermix® Zementpulver after the treatment (preparation) of teeth with dentine carious lesions and / or defective filling margins and reversible hyperaemia - Ledermix Zement

RIEMSER Arzneimittel AG0 个研究点开始时间: 2007年3月23日最近更新: 2012年3月19日

研究概览

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•male and female patients, aged 18-75 years
•caucasian origin
•Dentine carious lesions without clinical symptoms of inflammation (at maximum in 3 teeth)
•and / or defective filling margins
•test of vitality should be positive and percussion negative (in ALL teeth to be treated)
•Reversible hyperaemia (in ALL teeth to be treated)
•informed consent given in a written form after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the test drug and reference drug
•maximum VAS rating of 50 (of 100) before treatment (baseline)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years)
•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

•Symptomatology of existing irreversible chronic or acute pulpitis, non-vital responding teeth (necrotic pulps with or without periapical inflamatory clinical and/or radiolgical signs) and teeth with previously endodontic treatment.
•known intolerance to one of the ingredients of test/reference drug
•pregnancy or lactation in female patients
•current or previous participation in another clinical trial within the last 12 weeks
•Concomitant medication or procedures which would interfere with trial medication (like pre-treatment with a strong analgesic (opiate/narcotic) or analgesics within the first 12 hours after treatment and with extended duration of effect
•legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
•unreliability or lack of cooperation and compliance
•other objections to participate in the study in the opinion of the investigator
•diseases in which the sensitivity of the nervous system is altered (f.e. antidepression therapy, antirheumatic therapy)
•Patients who are receiving immunosuppression therapy

发起方