Moxifloxacin in Situ Gel to Treat Periodontal Pocket.
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|ClinicalTrials.gov Identifier: NCT02016157|
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : December 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Generalized Periodontitis||Drug: Moxifloxacin||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Care Provider, Investigator)|
|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|
Experimental: Moxifloxacin, Chronic periodontitis
50 micrograms Moxifloxacin
TO ASSESS THE EFFICACY OF MOXIFLOXACIN IN SITU GEL IN THE TREATMENT OF PERIODONTAL POCKET.
Other Name: Avelox
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02016157
|Sri Hasanamba Dental College & Hospital|
|Hassan, Karnataka, India, 573201|
|Principal Investigator:||Shaurya Manjunath, MDS||Rajiv Gandhi University of Health Sceinces, Bangalore,Karnataka, India|