Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on Patients With Chronic Periodontitis
Information source: Facultad Nacional de Salud Publica
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Periodontitis
Intervention: moxifloxacin (Drug); Ciprofloxacin plus metronidazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Facultad Nacional de Salud Publica Official(s) and/or principal investigator(s): Carlos M Ardila, DDS Cand PhD, Principal Investigator, Affiliation: Grupo Epidemiologia Universidad de Antioquia
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 to scaling and root planning for the treatment of advanced chronic
periodontitis.
Clinical Details
Official title: Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole as Adjunctive Therapy to Mechanical Treatment of Patients With Chronic Periodontitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Probing Depth
Secondary outcome: Subjective perception of treatment outcome, attachment gain,bleeding on probing, and full mouth plaque score.Microbial colonization dynamic
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 mechanical removal of the biofilm. However, outcome is variable.
According to recent EFP and AAP reviews, adjunctive antimicrobial therapy may be
beneficial. However, bearing in mind that Colombia has reported the frequent presence of
Enterobacteriaceae (Klebsiella and Enterobacter) in subgingival plaque of patients with
chronic periodontitis, the response to treatment may be different. The enteric have shown
resistance to amoxicillin, amoxicillin / clavulanate, metronidazole and tetracycline in
studies conducted in the United States, Norway, Brazil and Colombia. Although the combination
ciprofloxacin metronidazole has been recommended in the dental literature are not known
publications that demonstrate its effectiveness against periodontopathogens and enteric
present in subgingival plaque of subjects with chronic periodontitis. On the other hand, some
in vitro studies have demonstrated the effectiveness of moxifloxacin against
periodontopathogens, but was not aware of any clinical trials or in vitro studies on
antibiotic resistance and susceptibility to enteric isolated subgingival plaque of patients
with chronic periodontitis in which employs moxifloxacin.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Faculta Nacional de Salud Publica Universidad de Antioquia, Medellin, Antioquia 057-4, Colombia
Additional Information
Starting date: February 2009
Last updated: May 10, 2010
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