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OpenTrials
Completed

NCT Number: NCT02016157

Moxifloxacin in Situ Gel to Treat Periodontal Pocket.

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sri Hasanamba Dental College & Hospital

Hassan, Karnataka, 573201, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

moxifloxacin

Drug

TO ASSESS THE EFFICACY OF MOXIFLOXACIN IN SITU GEL IN THE TREATMENT OF PERIODONTAL POCKET.

Other names: Avelox

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sri Hasanamba Dental College and Hospital

Other

Registry information

Official study title

Moxifloxacin In Situ Gel as an Adjunct in the Treatment of Periodontal Pocket: A Randomized Clinical Trial.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 19, 2013
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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