Adjunctive antimicrobial therapy of Periodontitis: long-term effects on disease progression and oral microbiological colonisatio

Phase 4

Completed

• Conditions: Periodontology; Oral Health

• Registration Number: ISRCTN64254080
• Lead Sponsor: niversity Hospital Muenster (Germany)

Brief Summary

2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26250060 (added 19/02/2019) 2016 sub-analysis results in: https://www.ncbi.nlm.nih.gov/pubmed/27393928 (added 19/02/2019) 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30326764 (added 19/02/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-30
• Study Completion: 2012-01-01
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified