Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization
Information source: University Hospital Muenster
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Periodontitis
Intervention: Amoxicillin and Metronidazole (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital Muenster Official(s) and/or principal investigator(s):
Benjamin - Ehmke, PhD, Principal Investigator, Affiliation: University Hospital Muenster, Dept. of Periodontology
Overall contact:
Benjamin - Ehmke, PhD, Phone: 49-025-1834-7059, Email: ehmke@uni-muenster.de
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.
Clinical Details
Official title: Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Percentage of sites showing attachment loss ≥ 1.3 mm over a 27.5-months period
Secondary outcome: Subjective perception of treatment outcome, attachment gain, pocket probing depths, bleeding on probing, and full mouth plaque score. Microbial colonization dynamic.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Benjamin - Ehmke, PhD, Phone: 49-025-1834-7059, Email: ehmke@uni-muenster.de
University Hospital Muenster, Dept. of Periodontology, Muenster 48149, Germany; Recruiting
Benjamin - Ehmke, PhD, Phone: 49-025-1834-7059, Email: ehmke@uni-muenster.de
Inga - Schaefer, DDS, Phone: 49-025-1834-7059, Email: inga.schaefer@ukmuenster.de
Benjamin - Ehmke, PhD, Principal Investigator
Inga - Schaefer, DDS, Sub-Investigator
Medizinische Fakultät der Humboldt Universität Berlin (Charité), Berlin 13353, Germany; Recruiting
Peter - Purucker, DDS, Phone: 49-030-4505-62641, Email: peter.purucker@charite.de
Peter - Purucker, DDS, Principal Investigator
Universitätsklinikum Carl Gustav Carus, Zentrum für Zahn-, Mund- und Kieferheilkunde, Dresden 01307, Germany; Recruiting
Thomas - Hoffmann, Prof. Dr., Phone: 49-035-1458-2712, Email: thomas.hoffmann@uniklinikum-dresden.de
Thomas - Hoffmann, Prof. Dr., Principal Investigator
Zentrum der Zahn-, Mund- und Kieferheilkunde (Carolinum), Poliklinik für Parodontologie, Frankfurt 60590, Germany; Recruiting
Peter - Eickholz, Prof. Dr., Phone: 49-069-6301-5642, Email: eickholz@med.uni-frankfurt.de
Peter - Eickholz, Prof. Dr., Principal Investigator
Justus-Liebig-Universität Gießen, Poliklinik für Parodontologie, Giessen 35392, Germany; Recruiting
Joerg - Meyle, Prof. Dr., Phone: 49-064-1994-6191, Email: joerg.meyle@dentist.med.uni-giessen.de
Joerg - Meyle, Prof. Dr., Principal Investigator
Universitätsklinikum Greifswald, Poliklinik für Zahnerhaltung, Parodontologie und Kinderzahnheilkunde, Greifswald 17487, Germany; Recruiting
Thomas - Kocher, Prof. Dr., Phone: 49-038-3486-7172, Email: kocher@uni-greifswald.de
Thomas - Kocher, Prof. Dr., Principal Investigator
Universitätsklinikum Heidelberg, Poliklinik für Zahnerhaltungskunde, Sektion Parodontologie, Heidelberg 69120, Germany; Recruiting
Ti.Sun Kim, PhD, Phone: 49-062-2156-6002, Email: ti-sun_kim@med.uni-heidelberg.de
Ti-Sun - Kim, PhD, Principal Investigator
Universität Würzburg, Poliklinik für Parodontologie, Würzburg 97070, Germany; Recruiting
Ulrich - Schlagenhauf, Prof. Dr., Phone: 49-093-1201-72620, Email: schlagenhauf@psychologie.uni-wuerzburg.de
Ulrich - Schlagenhauf, Prof. Dr., Principal Investigator
Additional Information
Starting date: June 2008
Ending date: September 2011
Last updated: July 1, 2008
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