Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02016157
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2013-11-06
Brief Title:
Moxifloxacin in Situ Gel to Treat Periodontal Pocket
Sponsor:
Sri Hasanamba Dental College and Hospital
Organization:
Sri Hasanamba Dental College and Hospital
Study Overview
Official Title:
Moxifloxacin In Situ Gel as an Adjunct in the Treatment of Periodontal Pocket A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None