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| Adjunctive antimicrobial therapy of Periodontitis: long-term effects on disease progression and oral microbiological colonisation |
| ISRCTN | ISRCTN64254080 |
| ClinicalTrials.gov identifier | NCT00707369 |
| Public title | Adjunctive antimicrobial therapy of Periodontitis: long-term effects on disease progression and oral microbiological colonisation |
| Scientific title | |
| Acronym | ABPARO |
| Serial number at source | EH 365/1-1 |
| Study hypothesis |
Please note that as of 01/08/2008 this record has been updated. All updated can be found in the relevant field under the above update date. Please note that the anticipated start and end dates of this trial have also been updated. The previous dates were as follows:
Previous anticipated start date: 01/09/2007 Previous anticipated end date: 01/11/2011 Please also note that the acronym has been updated to the above; the previous acronym was 'AP'. Current hypothesis as of 01/08/2008: 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. Previous hypothesis: 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 26-month period in a statistical and clinical significant manner. |
| Lay summary | |
| Ethics approval | Approval received from the local ethics committee (Ethikkommission der Aerztekammer Westfalen-Lippe und der Med. Fakultaet der Westfaelischen Wilhelms-Universtitaet Muenster) on the 21st December 2006 (ref: 2006-474-f-A). |
| Study design | Double-blind, parallel group, randomised, placebo-controlled, multi-centre, phase IV efficacy study |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Periodontology |
| Participants - inclusion criteria |
Current inclusion criteria as of 01/08/2008:
Subjects selected for the study must meet the following inclusion criteria: 1. Periodontal Screening Index (PSI) of IV in at least one sextant 2. Range from 18 to 75 years of age with 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 3. At least 10 natural teeth in situ 4. Pocket Probing Depths (PPDs) of greater than or equal to 6 mm at a minimum of four teeth 5. Willingness to participate and to be available at all times required for participation 6. Willingness to abstain from using antimicrobial mouth-rinses during the study except for those explicitly prescribed 7. The informed consent signed by the patient 8. Sufficient knowledge of German language Previous inclusion criteria: Subjects selected for the study must meet the following inclusion criteria: 1. Periodontal Screening Index (PSI) of IV in at least one sextant 2. Range from 18 to 75 years of age with 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 3. At least 10 natural teeth in situ 4. Pocket Probing Depths (PPDs) of greater than or equal to 6 mm at a minimum of four teeth 5. No professional periodontal therapy during the six months preceding the baseline clinical evaluation, and willingness to participate and to be available at all times required for participation 6. Willingness to abstain from using antimicrobial mouth-rinses during the study except for those explicitly prescribed 7. The informed consent signed by the patient |
| Participants - exclusion criteria |
Current exclusion criteria as of 01/08/2008:
1. Report themselves confirmed or assumed allergies or hyper-sensitive skin reactions against amoxicillin, metronidazol or lactose, or in parents or siblings 2. Have Downs syndrome 3. Known acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV) 4. Regularly take drugs that may affect the periodontal conditions, e.g. phenytoine, nifedipine, and/or steroid drugs 5. Professional periodontal therapy during the six months preceding the baseline clinical evaluation 6. Require antibiotic treatment for dental appointments 7. Are undergoing or require extensive dental or orthodontic treatment 8. Are pregnant or breastfeeding 9. Have rampant caries 10. Have any oral or extra-oral piercing in or around the oral cavity with ornaments or accessory jewellery 11. Are dental students or dental professionals 12. Have participated in a clinical dental trial in the six months preceding the study 13. Cognitive deficits Previous exclusion criteria: 1. Report themselves confirmed or assumed allergies or hyper-sensitive skin reactions against amoxicillin, metronidazole or lactose, or in parents or siblings 2. Have Down’s syndrome, known Acquired Immune Deficiency Syndrome (AIDS)/Human Immunodeficiency Virus (HIV) or deregulated diabetes type one or two as determined by assessment of erythrocyte HbA1c levels (more than 6.5%) 3. Regularly take drugs that may affect the periodontal conditions, e.g. phenytoine, nifedipine, and/or steroid drugs 4. Require antibiotic treatment for dental appointments 5. Are undergoing or require extensive dental or orthodontic treatment 6. Are pregnant or breastfeeding 7. Have rampant caries 8. Have any oral or extra-oral piercing in or around the oral cavity with ornaments or accessory jewellery 9. Are dental students or dental professionals, or have participated in a clinical dental trial in the six months preceding the study 10. Cognitive deficits 11. Insufficient knowledge of German language |
| Anticipated start date | 01/07/2008 |
| Anticipated end date | 01/01/2012 |
| Status of trial | Completed |
| Patient information material | Patient information can be found at: http://www.abparo.de/patienten.shtml |
| Target number of participants | 500 |
| Interventions |
Experimental intervention:
Mechanical debridement plus 500 mg amoxicillin and 400 mg metronidazole three times daily for seven days. Supportive periodontal therapy in three-month intervals. Control intervention: Mechanical debridement alone. Supportive periodontal therapy in three-month intervals. Duration of intervention per patient: 27.5 months. The control intervention represents the gold standard in periodontal therapy. There are no additional risks of adverse effects for the participating control group patients that go beyond the risks associated with periodontal standard care. The major risk for both groups is associated with the local anaesthesia (cardiac or anaphylactic reactions, trauma of the lingual and/or lower mandibular nerve, and infections). A minor adverse effect of subgingival debridement might be root hypersensitivity. For the test group patients, the administration of systemic antibiotics (allergic reaction, gastrointestinal discomfort, pseudomembranous colitis, neurological disorders, urticaria, and drug interactions) is an additional risk. However, severe adverse effects caused by the intake of amoxicillin plus metronidazole are extremely rare. The expected benefits are a reduction of the intraoral periodontal pathogenic microflora and due to that, a decrease of the amount of sites losing tooth supporting tissues. We expect that the adjunctive antibiotic therapy reduces further tooth loss and will improve the patient’s quality of life. Sponsor amended as of March 2009 to that of below; initial sponsor information at the time of registration: Westfälische Wilhelms University of Muenster (Germany) |
| Primary outcome measure(s) | Percentage of sites showing attachment loss greater than or equal to 1.3 mm over a 27.5-months period. |
| Secondary outcome measure(s) |
1. Subjective perception of treatment outcome
2. Attachment gain 3. Pocket probing depths 4. Bleeding on probing 5. Full mouth plaque score 6. Microbial colonisation dynamic All secondary outcomes will be measured at 3.5, 15.5, and 27.5 months after therapy. At 9.5 and 21.5 no microbiological samples will be taken, and at 6.5 months, only microbiological samples will be taken. |
| Sources of funding | German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany) (ref: EH 365/1-1) |
| Trial website | http://www.abparo.de |
| Publications | |
| Contact name | Prof Dr Benjamin Ehmke |
| Address |
University of Münster
Department of Periodontology Waldeyerstr. 30 |
| City/town | Münster |
| Zip/Postcode | 48149 |
| Country | Germany |
| Tel | +49 (0)251 834 7059 |
| Fax | +49 (0)251 834 7134 |
| ehmke@uni-muenster.de | |
| Sponsor | University Hospital Muenster (Germany) |
| Address |
c/o Dr. Christoph Hoppenheit
Kaufmännischer Direktor Domagkstr. 5 |
| City/town | Münster |
| Zip/Postcode | 48149 |
| Country | Germany |
| Christoph.Hoppenheit@ukmuenster.de | |
| Sponsor website: | http://klinik.uni-muenster.de/ |
| Date applied | 09/03/2007 |
| Last edited | 18/03/2009 |
| Date ISRCTN assigned | 30/03/2007 |
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| © 2012 ISRCTN unless otherwise stated. | |
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