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Completed

NCT Number: NCT00805558

Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculta Nacional de Salud Publica Universidad de Antioquia

Medellín, Antioquia, 057-4, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moxifloxacin

Drug

400 mg moxifloxacin once daily for 7 days

Other names: Moxifloxacin hydrochloride

Ciprofloxacin plus metronidazole

Drug

Ciprofloxacin 1000 mg once daily for 7 days; Metronidazole 500 mg twice daily for 7 days

Other names: ciprofloxacino, metronidazole benzoato

Primary outcomes

  1. Probing Depth

    Time frame: six months period (two measurements)

Secondary outcomes

  1. Subjective perception of treatment outcome, attachment gain,bleeding on probing, and full mouth plaque score.

    Time frame: six months

  2. Microbial colonization dynamic

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Facultad Nacional de Salud Publica

Other

Collaborators

  • Universidad de Antioquia

Registry information

Official study title

Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole as Adjunctive Therapy to Mechanical Treatment of Patients With Chronic Periodontitis

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Dec 9, 2008
Registry last updated
May 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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