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Moxifloxacin in Situ Gel to Treat Periodontal Pocket.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02016157
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : December 19, 2013
Information provided by (Responsible Party):
Dr. Shaurya Manjunath, Sri Hasanamba Dental College and Hospital

Tracking Information
First Submitted Date  ICMJE November 6, 2013
First Posted Date  ICMJE December 19, 2013
Last Update Posted Date December 19, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2013)
Change from baseline in Clinical attachment level at 3 months in chronic periodontitis patients [ Time Frame: 3 months ]
The present randomized clinical trial assessed the effects of moxifloxacin, compared with chlorhexidine, locally administered via in situ gel formulation, on various clinical parameters describing periodontitis.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Moxifloxacin in Situ Gel to Treat Periodontal Pocket.
Official Title  ICMJE Moxifloxacin In Situ Gel as an Adjunct in the Treatment of Periodontal Pocket: A Randomized Clinical Trial.
Brief Summary In this Randomized clinical trial locally delivered moxifloxacin in situ gel was evaluated as an adjunct to scaling and root planing for efficacy in the treatment of chronic periodontitis and for short-term effects on the periodontal microflora.
Detailed Description

Moxifloxacin exerts excellent antibacterial activity against a wide range of putative periodontal pathogens, including Porphyromonas gingivalis, Tannerella forsythia, Prevotella species, Fusobacterium nucleatum, Actinomyces species, Peptostreptococcus species, Campylobacter rectus, and Actinobacillus actinomycetemcomitans. Moxifloxacin penetrates well into soft tissues and is effective against intracellular periodontal pathogens when used in the treatment of periodontitis as an adjunct to scaling and root planning (SRP). Systemic administration of moxifloxacin has provided superior outcomes compared with SRP in conjunction with systemic administration of doxycycline, or SRP alone. We hypothesized similar benefits with local drug delivery of Moxifloxacin in the treatment of chronic periodontitis. To the best of our knowledge, there is no published literature on in situ gel using moxifloxacin employing gellan gum as the vehicle, for direct placement in the periodontal pocket for the treatment of chronic periodontitis.

Among various drug delivery systems for treating periodontitis, gel formulations have some advantages. Despite a relatively faster release of the drug, gels can be more easily prepared and administered. Moreover, they possess a higher bio compatibility and bio adhesivity, by allowing adhesion to the mucosa in the dental pocket and by decreasing the risk of dilution of the material by saliva.

Keeping the above facts in mind, the goals of this study were to (1) evaluate in situ gel as a vehicle in a local drug delivery system, (2) evaluate the efficacy of moxifloxacin for local drug delivery, (3) evaluate the efficacy of gellan gum for in situ gelation of moxifloxacin, and (4) evaluate and compare the clinical and microbiological parameters of moxifloxacin with those of the gold standard, chlorhexidine di gluconate.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Generalized Periodontitis
Intervention  ICMJE Drug: Moxifloxacin
Other Name: Avelox
Study Arms  ICMJE Experimental: Moxifloxacin, Chronic periodontitis
50 micrograms Moxifloxacin
Intervention: Drug: Moxifloxacin
Publications * Guentsch A, Jentsch H, Pfister W, Hoffmann T, Eick S. Moxifloxacin as an adjunctive antibiotic in the treatment of severe chronic periodontitis. J Periodontol. 2008 Oct;79(10):1894-903. doi: 10.1902/jop.2008.070493 .

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2013)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with good systemic health
  • Patients with Chronic periodontitis with sites with probing pocket depth (PPD) of ≥ 5 mm
  • a minimum of 12 natural teeth with radiographic evidence of bone loss
  • willingness to comply with the study protocol.

Exclusion Criteria:

  • Patients with a history of drug allergy to quinolones or those who were taking medication that might interact with moxifloxacin
  • Patients with history of antibiotic coverage in the 6 months preceding the study
  • Pregnant or lactating patients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02016157
Other Study ID Numbers  ICMJE Shaurya Manjunath
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Shaurya Manjunath, Sri Hasanamba Dental College and Hospital
Study Sponsor  ICMJE Sri Hasanamba Dental College and Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shaurya Manjunath, MDS Rajiv Gandhi University of Health Sceinces, Bangalore,Karnataka, India
PRS Account Sri Hasanamba Dental College and Hospital
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP