Clinical Trial: Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on Patients With Chronic Periodontitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole as Adjunctive Therapy to Mechanical Treatment of Patients With Chronic Periodontitis
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 to scaling and root planning for the treatment of advanced chronic periodontitis.
Detailed Summary: 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.
Sponsor: Facultad Nacional de Salud Publica
Current Primary Outcome: Probing Depth [ Time Frame: six months period (two measurements) ]
Original Primary Outcome: Percentage of sites showing attachment loss [ Time Frame: six months period (two measurements) ]
Current Secondary Outcome:
- Subjective perception of treatment outcome, attachment gain,bleeding on probing, and full mouth plaque score. [ Time Frame: six months ]
- Microbial colonization dynamic [ Time Frame: six months ]
Original Secondary Outcome: Subjective perception of treatment outcome, attachment gain, pocket probing depths, bleeding on probing, and full mouth plaque score. Microbial colonization dynamic [ Time Frame: six months ]
Information By: Facultad Nacional de Salud Publica
Dates:
Date Received: December 8, 2008
Date Started: February 2009
Date Completion:
Last Updated: May 10, 2010
Last Verified: October 2009
