Status:
COMPLETED
Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization
Lead Sponsor:
University Hospital Muenster
Conditions:
Periodontitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 representat...
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 mechan...
Eligibility Criteria
Inclusion
- periodontal screening index (PSI) of IV in at least one sextant;
- range from 18 to 75 years of age;
- clinical and radiographic signs of moderate (clinical attachment loss \[CAL\] of 3 to 4 mm) to severe (CAL 5 mm or more) chronic or aggressive periodontitis;
- at least 10 natural teeth in situ;
- pocket probing depths (PPDs) of ≥ 6 mm at a minimum of four teeth;
- willingness to participate and to be available at all times required for participation;
- willingness to abstain from using antimicrobial mouth-rinses during the study except for those explicitly prescribed;
- informed consent signed by the patient;
- sufficient knowledge of German language.
Exclusion
- if they (or parents or siblings) show confirmed or assumed allergies or hyper-sensitive skin reactions against amoxicillin (or other penicillins or other ingredients of Amoxicillin-ratiopharm® 500mg as listed in the "summary of product characteristics, Version Juli 2005"), metronidazole (or other 5-nitroimidazoles and ingredients of Flagyl® 400mg as listed in the "summary of product characteristics, Version Juli 2007"), systemic diseases or conditions as listed in the above mentioned "summary of product characteristics", or show confirmed lactose intolerance;
- have Down's syndrome;
- known AIDS/HIV;
- regularly take systemic medication affecting the periodontal conditions, e.g. phenytoin, nifedipine, and/or steroid drugs;
- professional periodontal therapy during 6 months prior to baseline;
- require antibiotic treatment for dental appointments;
- are undergoing or require extensive dental or orthodontic treatment;
- are pregnant or breastfeeding;
- have rampant caries;
- any oral or extraoral piercing in or around the oral cavity with ornaments or accessory jewelry;
- are dental students or dental professionals;
- have participated in a clinical dental trial in the six months preceding the study;
- cognitive deficits.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00707369
Start Date
October 1 2008
End Date
January 1 2012
Last Update
March 3 2015
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Medizinische Fakultät der Humboldt Universität Berlin (Charité)
Berlin, Germany, 13353
2
Universitätsklinikum Carl Gustav Carus, Zentrum für Zahn-, Mund- und Kieferheilkunde
Dresden, Germany, 01307
3
Zentrum der Zahn-, Mund- und Kieferheilkunde (Carolinum), Poliklinik für Parodontologie
Frankfurt, Germany, 60590
4
Justus-Liebig-Universität Gießen, Poliklinik für Parodontologie
Giessen, Germany, 35392