Clinical Trial: Alternative Antibiotic Regime in the Treatment of GAgP

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Evaluation of Systemic Moxifloxacin Compared to Amoxicillin Plus Metronidazole Adjunct to Non-surgical Treatment in Generalized Aggressive Periodontitis: A Random

Brief Summary:

The objective of this randomized clinical study was to evaluate the effect of systemic administration of moxifloxacin compared to amoxicillin plus metronidazole combined with non-surgical treatment in patients with generalized aggressive periodontitis (GAgP) in 6-month follow-up.

A total of 40 systemically healthy patients with GAgP will evaluate in this randomized clinical trial. Periodontal parameters (plaque index, gingival index, probing depth, bleeding on probing, clinical attachment level) will be recorded at baseline, 1st, 3rd and 6th month. Patients will receive either 400 mg moxifloxacin per os once daily or 500 mg metronidazole and 500 mg amoxicillin per os three times daily for 7 days consecutively.


Detailed Summary:

The American Academy of Periodontology and the European Federation of Periodontology were reported that patients with GAgP may have benefit from adjunctive administration of antibiotics. Antibiotics are used as an adjunct to nonsurgical treatment either locally or systemically. Systemic antimicrobial agents as adjunct to nonsurgical treatment provide additional benefits over mechanical therapy alone in terms of probing depth reduction and periodontal attachment gain.

Amoxicillin is a moderate spectrum, bacteriolytic β-lactam antibiotic, and metronidazole which is active against anaerobic bacteria is a nitroimidazole. scaling and root planing combination with metronidazole plus amoxicillin therapy was found to be more effective in suppressing P. gingivalis and eradication of A. actinomycetemcomitans and preventing re-colonization of A. actinomycetemcomitans because of the synergistic effect of this combination and their wide spectrum of activity. It was found to be superior to azithromycin, doxycycline, and metronidazole in the treatment of GAgP.

Quinolones were introduced for use in urinary tract infections in the 1970s. Moxiflocaxin is a fourth generation fluoroquinolone antibiotic exhibits good tissue penetration and high oral bioavailability and has improved activity against Gram- positive, aerobic and anaerobes. Moxifloxacin is used in the systemic treatment of respiratory infections, acute sinusitis, odontogenic abscesses, osteomyelitis of the mandible and locally in the treatment of ophthalmic infections.

Moxiflocaxin has good activity against putative periodontal pathogens, including Porphyromonas gingivalis, Tanneralla forsythia, Prevotella spp, Fusobacterium nucleatum, Actinomyces spp, Campylobacter rectus, Peptostreptococcus spp. and Aggregatibacter actinomyc
Sponsor: Kocaeli University

Current Primary Outcome: The primary outcome variable was probing depth changes. [ Time Frame: 6-months ]

We measured the probing depth at baseline, 1st, 3rd and 6th months. The changes were evaluated among and between groups.


Original Primary Outcome: Same as current

Current Secondary Outcome: The attachment loss were considered as a secondary measure. [ Time Frame: 6-months ]

Attachment loss were recorded at baseline, 1st, 3rd and 6th months as millimeters. The data were compared among and between groups.


Original Secondary Outcome: Same as current

Information By: Kocaeli University

Dates:
Date Received: August 20, 2014
Date Started: May 2011
Date Completion:
Last Updated: August 20, 2014
Last Verified: August 2014