Status:
COMPLETED
Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on Patients With Chronic Periodontitis
Lead Sponsor:
Facultad Nacional de Salud Publica
Collaborating Sponsors:
Universidad de Antioquia
Conditions:
Chronic Periodontitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the clinical and microbiological effectiveness of the moxifloxacin compared with the combination ciprofloxacin - metronidazole, when used as adjunctive therapy t...
Detailed Description
Periodontitis is an endemic inflammatory disease caused by a mixed bacterial biofilm infection that is followed by destruction of tooth supporting tissues. Standard of care consists of lifelong mechan...
Eligibility Criteria
Inclusion
- 18 years of age and up
- clinical and radiographic signs of severe (CAL 5 mm or more) chronic periodontitis.
- at least 20 natural teeth in situ
- pocket probing depths (PPDs) of ≥ 5 mm at a minimum of eight tooth sites
- willingness to participate and to be available at all times required for participation
- over 30% of the teeth present must have a PPDs)≥ 4 mm and insertion loss ≥ 5 mm evaluated by an experienced periodontist
- informed consent signed by the patient
Exclusion
- if they (or parents or siblings) show confirmed or assumed allergies or hyper-sensitive skin reactions against moxifloxacin, ciprofloxacin (or other quinolones as listed in the "summary of product characteristics, Version Juli 2005"), metronidazole (or other 5-nitroimidazoles and ingredients of Flagyl® 400mg as listed in the "summary of product characteristics, Version Juli 2007"), systemic diseases or conditions as listed in the above mentioned "summary of product characteristics"
- subjects who have undergone antibiotic therapy three months before the start of the study under interrogation
- have Down's syndrome
- known AIDS/HIV
- regularly take systemic medication affecting the periodontal conditions, e.g. phenytoin, nifedipine, and/or steroid drugs
- professional periodontal therapy during 6 months prior to baseline
- require antibiotic treatment for dental appointments
- are pregnant or breastfeeding
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00805558
Start Date
February 1 2009
End Date
April 1 2010
Last Update
May 12 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Faculta Nacional de Salud Publica Universidad de Antioquia
Medellín, Antioquia, Colombia, 057-4