NCT00707369

Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the size of the benefit of an adjunctive empiric antibiotic therapy compared to standard mechanical debridement and oral hygiene instructions in a representative sample of German periodontitis patients.

Detailed description

Periodontitis is an endemic inflammatory disease caused by a mixed bacterial biofilm infection that is followed by destruction of tooth supporting tissues. Standard of care consists of lifelong mechanical removal of the biofilm. However, outcome is variable. According to recent EFP and AAP reviews, adjunctive antimicrobial therapy may be beneficial. We plan to conduct a double-blind, parallel group, randomized, placebo-controlled multi-center efficacy study that addresses the following objectives: 1. What is the size of the benefit of an adjunctive empiric antibiotic therapy compared to standard mechanical debridement and oral hygiene instructions in a representative sample of German periodontitis patients? 2. 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? 3. Is the presence of specific microbial complexes a useful predictor of outcome and recurrence of periodontitis? 4. Does the administration of the antibiotic therapy affect the "oral health related quality of life"? The primary hypothesis tested is: the administered empiric adjunctive antibiotic therapy reduces about one half of the proportion of sites with attachment loss compared to subgingival debridement alone over a 27.5-month period in a statistical and clinical significant manner. To test this hypothesis about 500 patients will be enrolled in the clinical trial. According to the intention-to-treat principle, the primary efficacy analysis will include all randomized subjects. In addition, a per-protocol analysis will be done.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DRUG	Amoxicillin and Metronidazole	tablets: Amoxicillin 3H2O 574 mg and 400 mg metronidazole three times daily for 7 days
DRUG	Placebo	Placebo tablets (cellulose powder, lactose monohydrate, magnesium stearate, microcrystalline cellulose): three times daily for 7 days

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2008-06-30
• Last updated: 2015-03-03

Locations

8 sites across 1 country: Germany