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

Sponsor:	University Hospital Muenster
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00707369

Purpose

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.

Condition	Intervention	Phase
Periodontitis	Drug: Amoxicillin and Metronidazole Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Metronidazole hydrochloride Metronidazole phosphate Metronidazole

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

Percentage of sites showing attachment loss ≥ 1.3 mm over a 27.5-months period [ Time Frame: 27.5-months period (six measurements) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	June 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
test: Experimental 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
control: Placebo Comparator Mechanical debridement plus two placebo tablets three times daily for 7 days. Supportive periodontal therapy in 3-month intervals.	Drug: Placebo Placebo tablets (cellulose powder, lactose monohydrate, magnesium stearate, microcrystalline cellulose): three times daily for 7 days

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:

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707369

Contacts

Contact: Benjamin - Ehmke, PhD	49-025-1834-7059	ehmke@uni-muenster.de
Contact: Inga - Schaefer, DDS	49-025-1834-7059	inga.schaefer@ukmuenster.de

Locations

Germany
University Hospital Muenster, Dept. of Periodontology	Recruiting
Muenster, Germany, 48149
Contact: Benjamin - Ehmke, PhD 49-025-1834-7059 ehmke@uni-muenster.de
Contact: Inga - Schaefer, DDS 49-025-1834-7059 inga.schaefer@ukmuenster.de
Principal Investigator: Benjamin - Ehmke, PhD
Sub-Investigator: Inga - Schaefer, DDS
Medizinische Fakultät der Humboldt Universität Berlin (Charité)	Recruiting
Berlin, Germany, 13353
Contact: Peter - Purucker, DDS 49-030-4505-62641 peter.purucker@charite.de
Principal Investigator: Peter - Purucker, DDS
Universitätsklinikum Carl Gustav Carus, Zentrum für Zahn-, Mund- und Kieferheilkunde	Recruiting
Dresden, Germany, 01307
Contact: Thomas - Hoffmann, Prof. Dr. 49-035-1458-2712 thomas.hoffmann@uniklinikum-dresden.de
Principal Investigator: Thomas - Hoffmann, Prof. Dr.
Zentrum der Zahn-, Mund- und Kieferheilkunde (Carolinum), Poliklinik für Parodontologie	Recruiting
Frankfurt, Germany, 60590
Contact: Peter - Eickholz, Prof. Dr. 49-069-6301-5642 eickholz@med.uni-frankfurt.de
Principal Investigator: Peter - Eickholz, Prof. Dr.
Universität Würzburg, Poliklinik für Parodontologie	Recruiting
Würzburg, Germany, 97070
Contact: Ulrich - Schlagenhauf, Prof. Dr. 49-093-1201-72620 schlagenhauf@psychologie.uni-wuerzburg.de
Principal Investigator: Ulrich - Schlagenhauf, Prof. Dr.
Universitätsklinikum Greifswald, Poliklinik für Zahnerhaltung, Parodontologie und Kinderzahnheilkunde	Recruiting
Greifswald, Germany, 17487
Contact: Thomas - Kocher, Prof. Dr. 49-038-3486-7172 kocher@uni-greifswald.de
Principal Investigator: Thomas - Kocher, Prof. Dr.
Universitätsklinikum Heidelberg, Poliklinik für Zahnerhaltungskunde, Sektion Parodontologie	Recruiting
Heidelberg, Germany, 69120
Contact: Ti.Sun Kim, PhD 49-062-2156-6002 ti-sun_kim@med.uni-heidelberg.de
Principal Investigator: Ti-Sun - Kim, PhD
Justus-Liebig-Universität Gießen, Poliklinik für Parodontologie	Recruiting
Giessen, Germany, 35392
Contact: Joerg - Meyle, Prof. Dr. 49-064-1994-6191 joerg.meyle@dentist.med.uni-giessen.de
Principal Investigator: Joerg - Meyle, Prof. Dr.

Sponsors and Collaborators

University Hospital Muenster

Investigators

Principal Investigator:

Benjamin - Ehmke, PhD

University Hospital Muenster, Dept. of Periodontology

More Information

No publications provided

Responsible Party:	Universitätsklinikum Münster, Poliklinik für Parodontologie, ( PD Dr. med. dent. Benjamin Ehmke )
Study ID Numbers:	EH 365/1-1, DFG grant: EH 365/1-1, ISRCTN : 64254080
Study First Received:	June 24, 2008
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00707369 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:

Periodontitis
Mechanical Debridement
Antibiotics
Attachment loss
Randomized controlled trial

Additional relevant MeSH terms:

Mouth Diseases
Anti-Infective Agents
Metronidazole
Antiprotozoal Agents
Disease Attributes
Amoxicillin
Physiological Effects of Drugs
Disease Progression
Pharmacologic Actions

Anti-Bacterial Agents
Antiparasitic Agents
Periodontal Diseases
Pathologic Processes
Radiation-Sensitizing Agents
Periodontitis
Therapeutic Uses
Stomatognathic Diseases

ClinicalTrials.gov processed this record on February 08, 2010