Moxifloxacin in Situ Gel to Treat Periodontal Pocket.

NCT ID: NCT02016157

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-11-30

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.

Conditions

Chronic Generalized Periodontitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moxifloxacin, Chronic periodontitis

50 micrograms Moxifloxacin

Group Type: EXPERIMENTAL

Moxifloxacin

Intervention Type: DRUG

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

Interventions

Moxifloxacin

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

Intervention Type: DRUG

Other Intervention Names

Avelox

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sri Hasanamba Dental College and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shaurya Manjunath

Shaurya Manjunath, Post graduate Student, Department of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaurya Manjunath, MDS

Role: PRINCIPAL_INVESTIGATOR

Rajiv Gandhi University of Health Sceinces, Bangalore,Karnataka, India

Locations

Sri Hasanamba Dental College & Hospital

Hassan, Karnataka, India

Countries

India

References

Guentsch A, Jentsch H, Pfister W, Hoffmann T, Eick S. Moxifloxacin as an adjunctive antibiotic in the treatment of severe chronic periodontitis. J Periodontol. 2008 Oct;79(10):1894-903. doi: 10.1902/jop.2008.070493.

Reference Type: BACKGROUND

PMID: 18834244 (View on PubMed)

Other Identifiers

Shaurya Manjunath

Identifier Type: -

Identifier Source: org_study_id