periodontal disease (moderate to severe) MedDRA version: 9.1 Level: LLT Classification code 10034539 Term: Periodontitis
Conditions
Interventions
Trade Name: Amoxicillin-rathiopharm
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: AMOXICILLIN
CAS Number: 26787780
Current Sponsor code: -
Other descriptive name: -
Concentration unit: mg mi
Sponsors
University Hospital Muenster
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Periodontal screening index of IV in at least one sextant; pocket probing depths of = 6 mm at a minimum of four teeth minimum of 10 teeth; age 18-75 years. 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: Systemic diseases or regular medications that may severely affect periodontal disease, pregnancy or breastfeeding, antibiotic prophylaxis required for dental appointments, allergies against the prescribed antibiotics and ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: What is the size of the benefit of an adjunctive antibiotic therapy compared to standard mechanical debridement and oral hygiene instructions in a representative sample of German periodontitis patients? ;Secondary Objective: Does the administration of the antibiotic therapy delay recurrence of periodontitis in the general population and in specific high risk groups (e.g. smokers) under standard supportive therapy? Is the presence of specific microbial complexes a useful predictor of outcome and recurrence of periodontitis? Does the administration of the antibiotic therapy affect the oral health related quality of life? ;Primary end point(s): Percentage of sites showing attachment loss = 1.3 mm over a 27.5-months period. | — |
Countries
Germany
Outcome results
None listed