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

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Phase 4

Locations

Colombia

Study Type

Interventional

Intervention

moxifloxacin

Ciprofloxacin plus metronidazole

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Chronic Periodontitis, antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculta Nacional de Salud Publica Universidad de Antioquia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moxifloxacin

Ciprofloxacin plus metronidazole

Arm Description

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

Scaling and root planing plus ciprofloxacin 1000 mg once daily for 7 days and metronidazole 500 mg twice daily for 7 days

Outcomes

Primary Outcome Measures

Probing Depth

Secondary Outcome Measures

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

Microbial colonization dynamic

Full Information

NCT ID

NCT00805558

First Posted

December 8, 2008

Last Updated

May 10, 2010

Sponsor

Facultad Nacional de Salud Publica

Collaborators

Universidad de Antioquia

1. Study Identification

Unique Protocol Identification Number

NCT00805558

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Facultad Nacional de Salud Publica

Collaborators

Universidad de Antioquia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

Keywords

Chronic Periodontitis, antibiotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moxifloxacin

Arm Type

Experimental

Arm Description

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

Arm Title

Ciprofloxacin plus metronidazole

Arm Type

Active Comparator

Arm Description

Scaling and root planing plus ciprofloxacin 1000 mg once daily for 7 days and metronidazole 500 mg twice daily for 7 days

Intervention Type

Drug

Intervention Name(s)

moxifloxacin

Other Intervention Name(s)

Moxifloxacin hydrochloride

Intervention Description

400 mg moxifloxacin once daily for 7 days

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin plus metronidazole

Other Intervention Name(s)

ciprofloxacino, metronidazole benzoato

Intervention Description

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

Primary Outcome Measure Information:

Title

Probing Depth

Time Frame

six months period (two measurements)

Secondary Outcome Measure Information:

Title

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

Time Frame

six months

Title

Microbial colonization dynamic

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos M Ardila, DDS Cand PhD

Organizational Affiliation

Grupo Epidemiologia Universidad de Antioquia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculta Nacional de Salud Publica Universidad de Antioquia

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

057-4

Country

Colombia

12. IPD Sharing Statement

Citations:

PubMed Identifier

20151809

Citation

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.

Results Reference

result

PubMed Identifier

20383102

Citation

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.

Results Reference

result

PubMed Identifier

33197289

Citation

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.

Results Reference

derived

Links:

URL

http://www.udea.edu.co

Description

Clinical trial of moxifloxacin in chronic periodontitis

Learn more about this trial

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

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