Teeth with dentine carious lesions without clinical symptoms of inflammation, and / or Teeth with defective filling margins
Conditions
Interventions
Trade Name: Ledermix® Zementpulver
Product Name: Ledermix® Zementpulver
Pharmaceutical Form: Powder and solvent for sealant
INN or Proposed INN: Demeclocycline hydrochloride
CAS Number: 64-73-3
Concen
Sponsors
RIEMSER Arzneimittel AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the clinical trial is to show that the increase of post traumatic irritation (pain) 12 hours after treatment of teeth with dentine carious lesions, defective filling margins and normal or excessive loss of hard tissue with Ledermix® Zementpulver is less or equivalent to the increase of pain after treatment with Provicol®.;Secondary Objective: 1. Pulp vitality 2. Necessity of Rescue medication (NSAR) 3. Percussion sensitivity 4. Requirement of additional consultation of the investigator by the patient within the overal period of 28?3 days of observation 5. Overall assessment of efficacy by the dentist and patient 6. Pain intensity in the course of the study ;Primary end point(s): The objective of the clinical trial is to show that the increase of post traumatic irritation (pain) 12 hours after treatment of teeth with dentine carious lesions, defective filling margins and normal or excessive loss of hard tissue with Ledermix® Zementpulver is less or equivalent to the increase of pain after treatment with Provicol®. | — |
Countries
Germany
Outcome results
None listed