Adjunctive antimicrobial therapy of periodontitis: Long-term effects on disease progression and oral microbiological colonization - Antibiotics and Periodontitis
- Conditions
- periodontal disease (moderate to severe)MedDRA version: 9.1Level: LLTClassification code 10034539Term: Periodontitis
- Registration Number
- EUCTR2006-005854-61-DE
- Lead Sponsor
- niversity Hospital Muenster
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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?<br>;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?<br>Is the presence of specific microbial complexes a useful predictor of outcome and recurrence of periodontitis?<br>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.
- Secondary Outcome Measures
Name Time Method