Periodontology Oral Health Periodontology
Conditions
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 inter
initial sponsor information at the time of registration: Westfälische Wilhelms University of Muenster (Germany)
Sponsors
University Hospital Muenster (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of sites showing attachment loss greater than or equal to 1.3 mm over a 27.5-months period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed