Periodontitis Clinical Trial
Official title:
Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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