Moxifloxacin in Situ Gel to Treat Periodontal Pocket.

Phase 4

Completed

• Conditions: Chronic Generalized Periodontitis
• Interventions: Drug: Moxifloxacin

• Registration Number: NCT02016157
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-09
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-19
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moxifloxacin, Chronic periodontitis	Moxifloxacin	50 micrograms Moxifloxacin

Primary Outcome Measures

Name	Time	Method
Change from baseline in Clinical attachment level at 3 months in chronic periodontitis patients	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.

Trial Locations

Locations (1)

Sri Hasanamba Dental College & Hospital; 🇮🇳 Hassan, Karnataka, India