Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization (ABPARO-Studie)
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|ClinicalTrials.gov Identifier: NCT00707369|
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : March 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Periodontitis||Drug: Amoxicillin and Metronidazole Drug: Placebo||Phase 4|
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:
- 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?
- 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"?
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2012|
Mechanical debridement plus 500 mg amoxicillin and 400 mg metronidazole three times daily for 7 days. Supportive periodontal therapy in 3-month intervals.
Drug: Amoxicillin and Metronidazole
tablets: Amoxicillin 3H2O 574 mg and 400 mg metronidazole three times daily for 7 days
Placebo Comparator: control
Mechanical debridement plus two placebo tablets three times daily for 7 days. Supportive periodontal therapy in 3-month intervals.
Placebo tablets (cellulose powder, lactose monohydrate, magnesium stearate, microcrystalline cellulose): three times daily for 7 days
- Percentage of sites showing attachment loss ≥ 1.3 mm over a 27.5-months period [ Time Frame: 27.5-months period (six measurements) ]
- Subjective perception of treatment outcome, attachment gain, pocket probing depths, bleeding on probing, and full mouth plaque score. Microbial colonization dynamic. [ Time Frame: over a 27.5-months period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707369
|Medizinische Fakultät der Humboldt Universität Berlin (Charité)|
|Berlin, Germany, 13353|
|Universitätsklinikum Carl Gustav Carus, Zentrum für Zahn-, Mund- und Kieferheilkunde|
|Dresden, Germany, 01307|
|Zentrum der Zahn-, Mund- und Kieferheilkunde (Carolinum), Poliklinik für Parodontologie|
|Frankfurt, Germany, 60590|
|Justus-Liebig-Universität Gießen, Poliklinik für Parodontologie|
|Giessen, Germany, 35392|
|Universitätsklinikum Greifswald, Poliklinik für Zahnerhaltung, Parodontologie und Kinderzahnheilkunde|
|Greifswald, Germany, 17487|
|Universitätsklinikum Heidelberg, Poliklinik für Zahnerhaltungskunde, Sektion Parodontologie|
|Heidelberg, Germany, 69120|
|University Hospital Muenster, Dept. of Periodontology|
|Muenster, Germany, 48149|
|Universität Würzburg, Poliklinik für Parodontologie|
|Würzburg, Germany, 97070|
|Principal Investigator:||Benjamin - Ehmke, PhD||University Hospital Muenster, Dept. of Periodontology|