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CompletedNCT00805558Updated May 12, 2010

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

A Phase 4 interventional study of moxifloxacin and Ciprofloxacin plus metronidazole in Chronic Periodontitis, sponsored by Facultad Nacional de Salud Publica. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-05-12.

Sponsored by Facultad Nacional de Salud Publica · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Periodontitis

Keywords

  • Chronic Periodontitis
  • antibiotics
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 76 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Facultad Nacional de Salud Publica is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Moxifloxacin

    Scaling and root planing plus 400 mg moxifloxacin once daily for 7 days.

    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

    Drug: Ciprofloxacin plus metronidazole

Interventions

  • Drugmoxifloxacin

    400 mg moxifloxacin once daily for 7 days

    Also known as: Moxifloxacin hydrochloride

  • DrugCiprofloxacin plus metronidazole

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

    Also known as: ciprofloxacino, metronidazole benzoato

06

What researchers measure

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

07

Study locations

1 site
  • Faculta Nacional de Salud Publica Universidad de Antioquia
    Medellin, Antioquia 057-4, Colombia
08

References and documents

Publications

  • Ardila CM, Fernandez N, Guzman IC. Antimicrobial susceptibility of moxifloxacin against gram-negative enteric rods from colombian patients with chronic periodontitis. J Periodontol. 2010 Feb;81(2):292-9. doi: 10.1902/jop.2009.090464. PubMed 20151809 ↗
  • Ardila CM, Lopez MA, Guzman IC. High resistance against clindamycin, metronidazole and amoxicillin in Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans isolates of periodontal disease. Med Oral Patol Oral Cir Bucal. 2010 Nov 1;15(6):e947-51. PubMed 20383102 ↗
  • Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2. PubMed 33197289 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00805558
Lead sponsor
Facultad Nacional de Salud Publica
Collaborators
Universidad de Antioquia
First posted
Dec 9, 2008
Start date
Feb 2009
Primary completion
Dec 2009
Completion
Apr 2010
Last update
May 12, 2010

Study contacts

Carlos M Ardila, DDS Cand PhD
principal investigator · Grupo Epidemiologia Universidad de Antioquia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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