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)
Investigators
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
Similar Trials
Completed
Phase 4
Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological ColonizationPeriodontitisNCT00707369University Hospital Muenster540
Active, not recruiting
Not Applicable
Adjunctive antimicrobial therapy of periodontitis: Long-term effects on disease progression and oral microbiological colonization - Antibiotics and Periodontitisperiodontal disease (moderate to severe)MedDRA version: 9.1Level: LLTClassification code 10034539Term: PeriodontitisEUCTR2006-005854-61-DEniversity Hospital Muenster
Completed
Phase 3
Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental PracticePeriodontitisPeriodontal DiseasesPeriodontal PocketNCT06131021Rutgers, The State University of New Jersey236
Completed
Phase 4
Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of TimingChronic PeriodontitisNCT02197260University of Geneva, Switzerland80
Recruiting
Phase 1
Is antibiotics required after periodontal surgeries for treating postsurgical complication.Health Condition 1: null- Patients with chronic periodontitisCTRI/2017/11/010490Amrita School of Dentistry