Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on Patients With Chronic Periodontitis

This study has been completed.
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by:
Facultad Nacional de Salud Publica
ClinicalTrials.gov Identifier:
NCT00805558
First received: December 8, 2008
Last updated: May 10, 2010
Last verified: October 2009

December 8, 2008
May 10, 2010
February 2009
December 2009   (final data collection date for primary outcome measure)
Probing Depth [ Time Frame: six months period (two measurements) ] [ Designated as safety issue: Yes ]
Percentage of sites showing attachment loss [ Time Frame: six months period (two measurements) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00805558 on ClinicalTrials.gov Archive Site
  • Subjective perception of treatment outcome, attachment gain,bleeding on probing, and full mouth plaque score. [ Time Frame: six months ] [ Designated as safety issue: Yes ]
  • Microbial colonization dynamic [ Time Frame: six months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on Patients With Chronic Periodontitis
Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole as Adjunctive Therapy to Mechanical Treatment of Patients With Chronic Periodontitis

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Periodontitis
  • Drug: moxifloxacin
    400 mg moxifloxacin once daily for 7 days
    Other Name: Moxifloxacin hydrochloride
  • Drug: Ciprofloxacin plus metronidazole
    Ciprofloxacin 1000 mg once daily for 7 days; Metronidazole 500 mg twice daily for 7 days
    Other Names:
    • ciprofloxacino
    • metronidazole benzoato
  • Experimental: Moxifloxacin
    Scaling and root planing plus 400 mg moxifloxacin once daily for 7 days.
    Intervention: Drug: moxifloxacin
  • Active Comparator: Ciprofloxacin plus metronidazole
    Scaling and root planing plus ciprofloxacin 1000 mg once daily for 7 days and metronidazole 500 mg twice daily for 7 days
    Intervention: Drug: Ciprofloxacin plus metronidazole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
April 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT00805558
ARD-0001-CM, CBEIH-SIU 08-44-203
Yes
Carlos Martín Ardila Medina, Grupo Epidemiologia Universidad de Antioquia
Facultad Nacional de Salud Publica
Universidad de Antioquia
Principal Investigator: Carlos M Ardila, DDS Cand PhD Grupo Epidemiologia Universidad de Antioquia
Facultad Nacional de Salud Publica
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP