Adjunctive antimicrobial therapy of Periodontitis: long-term effects on disease progression and oral microbiological colonisation
| ISRCTN | ISRCTN64254080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64254080 |
| ClinicalTrials.gov number | NCT00707369 |
| Secondary identifying numbers | EH 365/1-1 |
- Submission date
- 09/03/2007
- Registration date
- 30/03/2007
- Last edited
- 11/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Dr Benjamin Ehmke
Scientific
Scientific
University of Münster
Department of Periodontology
Waldeyerstr. 30
Münster
48149
Germany
| Phone | +49 (0)251 834 7059 |
|---|---|
| ehmke@uni-muenster.de |
Study information
| Study design | Double-blind, parallel group, randomised, placebo-controlled, multi-centre, phase IV efficacy study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.abparo.de/patienten.shtml |
| Scientific title | Adjunctive antimicrobial therapy of Periodontitis: long-term effects on disease progression and oral microbiological colonisation |
| Study acronym | ABPARO |
| 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. |
| Ethics approval(s) | 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). |
| Condition | Periodontology |
| Intervention | 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 patients 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) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Amoxicillin and metronidazole |
| Primary outcome measure | Percentage of sites showing attachment loss greater than or equal to 1.3 mm over a 27.5-months period. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/07/2008 |
| Overall study end date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Participant 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 |
| Participant 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 Downs 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 |
| Recruitment start date | 01/07/2008 |
| Recruitment end date | 01/01/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Münster
Münster
48149
Germany
48149
Germany
Sponsor information
University Hospital Muenster (Germany)
University/education
University/education
c/o Dr. Christoph Hoppenheit
Kaufmännischer Direktor
Domagkstr. 5
Münster
48149
Germany
| Christoph.Hoppenheit@ukmuenster.de | |
| Website | http://klinik.uni-muenster.de/ |
"ROR" |
https://ror.org/01856cw59 |
Funders
Funder type
Research organisation
German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany) (ref: EH 365/1-1)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2015 | 19/02/2019 | Yes | No |
| Results article | results | 01/02/2019 | 19/02/2019 | Yes | No |
| Results article | sub-analysis results | 01/10/2016 | 19/02/2019 | Yes | No |
Editorial Notes
11/04/2019: Internal review.
19/02/2019: Publication references added.
