Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization (ABPARO-Studie)

March 2, 2015 updated by: Benjamin Ehmke, University Hospital Muenster
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

540

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Medizinische Fakultät der Humboldt Universität Berlin (Charité)
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus, Zentrum für Zahn-, Mund- und Kieferheilkunde
      • Frankfurt, Germany, 60590
        • Zentrum der Zahn-, Mund- und Kieferheilkunde (Carolinum), Poliklinik für Parodontologie
      • Giessen, Germany, 35392
        • Justus-Liebig-Universität Gießen, Poliklinik für Parodontologie
      • Greifswald, Germany, 17487
        • Universitätsklinikum Greifswald, Poliklinik für Zahnerhaltung, Parodontologie und Kinderzahnheilkunde
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg, Poliklinik für Zahnerhaltungskunde, Sektion Parodontologie
      • Muenster, Germany, 48149
        • University Hospital Muenster, Dept. of Periodontology
      • Würzburg, Germany, 97070
        • Universität Würzburg, Poliklinik für Parodontologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test
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
Other Names:
  • Flagyl® 400 Filmtablette
  • Amoxicillin-ratiopharm® 500
Placebo Comparator: control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of sites showing attachment loss ≥ 1.3 mm over a 27.5-months period
Time Frame: 27.5-months period (six measurements)
27.5-months period (six measurements)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
over a 27.5-months period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Benjamin - Ehmke, PhD, University Hospital Muenster, Dept. of Periodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

June 24, 2008

First Submitted That Met QC Criteria

June 27, 2008

First Posted (Estimate)

June 30, 2008

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH 365/1-1
  • DFG grant: EH 365/1-1
  • ISRCTN : 64254080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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