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

NCT00805558 | Completed Phase 4 DMC

• 2 other identifiers: ARD-0001-CMCBEIH-SIU 08-44-203
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Chronic Periodontitis; antibiotics

Outcome Measures

Primary Outcomes (1)

• Probing Depth

  six months period (two measurements)

Secondary Outcomes (2)

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

  six months

• Microbial colonization dynamic

  six months

Study Arms (2)

Moxifloxacin

EXPERIMENTAL

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

Drug: moxifloxacin

Ciprofloxacin plus metronidazole

ACTIVE COMPARATOR

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

moxifloxacin DRUG

400 mg moxifloxacin once daily for 7 days

Also known as: Moxifloxacin hydrochloride

Moxifloxacin

Ciprofloxacin plus metronidazole DRUG

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

Also known as: ciprofloxacino, metronidazole benzoato

Ciprofloxacin plus metronidazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Facultad Nacional de Salud Publica: lead
• Universidad de Antioquia: collaborator

Study Sites (1)

Faculta Nacional de Salud Publica Universidad de Antioquia

Medellín, Antioquia, 057-4, Colombia

Location

Related Publications (3)

• 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.

  PMID: 20151809 RESULT

• 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.

  PMID: 20383102 RESULT

• 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.

  PMID: 33197289 DERIVED

Related Links

• Clinical trial of moxifloxacin in chronic periodontitis

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Moxifloxacin; Ciprofloxacin; Metronidazole

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Carlos M Ardila, DDS Cand PhD

  Grupo Epidemiologia Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: February 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: May 12, 2010

Record last verified: 2009-10

Locations

CO (1)