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Clinical Trials/ISRCTN64254080
ISRCTN64254080
Completed
Phase 4

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

niversity Hospital Muenster (Germany)0 sites500 target enrollmentMarch 30, 2007

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospital Muenster (Germany)
Enrollment
500
Status
Completed
Last Updated
6 years ago

Overview

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)

Registry
who.int
Start Date
March 30, 2007
End Date
January 1, 2012
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Hospital Muenster (Germany)

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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