Overview

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

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Facultad Nacional de Salud Publica
Collaborator:
Universidad de Antioquia
Treatments:
Ciprofloxacin
Fluoroquinolones
Metronidazole
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
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