- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00805558
Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on Patients With Chronic Periodontitis
May 10, 2010 updated by: Facultad Nacional de Salud Publica
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Antioquia
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Medellin, Antioquia, Colombia, 057-4
- Faculta Nacional de Salud Publica Universidad de Antioquia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Moxifloxacin
Scaling and root planing plus 400 mg moxifloxacin once daily for 7 days.
|
400 mg moxifloxacin once daily for 7 days
Other Names:
|
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
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Ciprofloxacin 1000 mg once daily for 7 days; Metronidazole 500 mg twice daily for 7 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Probing Depth
Time Frame: six months period (two measurements)
|
six months period (two measurements)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjective perception of treatment outcome, attachment gain,bleeding on probing, and full mouth plaque score.
Time Frame: six months
|
six months
|
Microbial colonization dynamic
Time Frame: six months
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Carlos M Ardila, DDS Cand PhD, Grupo Epidemiologia Universidad de Antioquia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
December 8, 2008
First Submitted That Met QC Criteria
December 8, 2008
First Posted (Estimate)
December 9, 2008
Study Record Updates
Last Update Posted (Estimate)
May 12, 2010
Last Update Submitted That Met QC Criteria
May 10, 2010
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Periodontitis
- Chronic Periodontitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Antiprotozoal Agents
- Antiparasitic Agents
- Cytochrome P-450 CYP1A2 Inhibitors
- Moxifloxacin
- Metronidazole
- Norgestimate, ethinyl estradiol drug combination
- Ciprofloxacin
Other Study ID Numbers
- ARD-0001-CM
- CBEIH-SIU 08-44-203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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