Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on Patients With Chronic Periodontitis - Full Text View

Sponsor:	Facultad Nacional de Salud Publica
Collaborator:	Universidad de Antioquia
Information provided by:	Facultad Nacional de Salud Publica
ClinicalTrials.gov Identifier:	NCT00805558

Purpose

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.

Condition	Intervention	Phase
Chronic Periodontitis	Drug: moxifloxacin Drug: Ciprofloxacin plus metronidazole	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole as Adjunctive Therapy to Mechanical Treatment of Patients With Chronic Periodontitis

Resource links provided by NLM:

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate Moxifloxacin Moxifloxacin hydrochloride Metronidazole

U.S. FDA Resources

Further study details as provided by Facultad Nacional de Salud Publica:

Primary Outcome Measures:

Probing Depth [ Time Frame: six months period (two measurements) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	76
Study Start Date:	February 2009
Study Completion Date:	April 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Moxifloxacin Scaling and root planing plus 400 mg moxifloxacin once daily for 7 days.	Drug: moxifloxacin 400 mg moxifloxacin once daily for 7 days Other Name: Moxifloxacin hydrochloride
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 Ciprofloxacin 1000 mg once daily for 7 days; Metronidazole 500 mg twice daily for 7 days Other Names: ciprofloxacino metronidazole benzoato

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805558

Locations

Colombia
Faculta Nacional de Salud Publica Universidad de Antioquia
Medellin, Antioquia, Colombia, 057-4

Sponsors and Collaborators

Facultad Nacional de Salud Publica

Universidad de Antioquia

Investigators

Principal Investigator:

Carlos M Ardila, DDS Cand PhD

Grupo Epidemiologia Universidad de Antioquia

More Information

Additional Information:

Clinical trial of moxifloxacin in chronic periodontitis This link exits the ClinicalTrials.gov site

Publications:

Ardila CM, Fernández N, Guzmán IC. Antimicrobial susceptibility of moxifloxacin against gram-negative enteric rods from colombian patients with chronic periodontitis. J Periodontol. 2010 Feb;81(2):292-9.

Ardila CM, López MA, Guzmán 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 Apr 11; [Epub ahead of print]

Responsible Party:	Carlos Martín Ardila Medina, Grupo Epidemiologia Universidad de Antioquia
ClinicalTrials.gov Identifier:	NCT00805558 History of Changes
Other Study ID Numbers:	ARD-0001-CM, CBEIH-SIU 08-44-203
Study First Received:	December 8, 2008
Last Updated:	May 10, 2010
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Facultad Nacional de Salud Publica:

Chronic Periodontitis
antibiotics

Additional relevant MeSH terms:

Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Ciprofloxacin
Moxifloxacin
Metronidazole
Norgestimate, ethinyl estradiol drug combination
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012