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Trial record 1 of 522 for:    MOXIFLOXACIN
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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

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.

Condition or disease Intervention/treatment Phase
Chronic Generalized Periodontitis Drug: Moxifloxacin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Moxifloxacin In Situ Gel as an Adjunct in the Treatment of Periodontal Pocket: A Randomized Clinical Trial.
Study Start Date : September 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Moxifloxacin, Chronic periodontitis
50 micrograms Moxifloxacin
Drug: Moxifloxacin
Other Name: Avelox

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02016157

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Sri Hasanamba Dental College & Hospital
Hassan, Karnataka, India, 573201
Sponsors and Collaborators
Sri Hasanamba Dental College and Hospital
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Principal Investigator: Shaurya Manjunath, MDS Rajiv Gandhi University of Health Sceinces, Bangalore,Karnataka, India

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Responsible Party: Dr. Shaurya Manjunath, Shaurya Manjunath, Post graduate Student, Department of Periodontology, Sri Hasanamba Dental College and Hospital Identifier: NCT02016157    
Other Study ID Numbers: Shaurya Manjunath
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013
Keywords provided by Dr. Shaurya Manjunath, Sri Hasanamba Dental College and Hospital:
In situ gel
Chronic periodontitis
Additional relevant MeSH terms:
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Periodontal Pocket
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs