Moxifloxacin in Situ Gel to Treat Periodontal Pocket.

Chronic Generalized Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016157
• Other study ID #: Shaurya Manjunath
• Status: Completed
• Phase: Phase 4
• Start date: September 2011
• Est. completion date: November 2012

Study information

• Verified date: August 2020
• Source: Sri Hasanamba Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Generalized Periodontitis
• Periodontal Pocket
• Periodontitis

Intervention

Drug:
• Moxifloxacin
TO ASSESS THE EFFICACY OF MOXIFLOXACIN IN SITU GEL IN THE TREATMENT OF PERIODONTAL POCKET.

Locations

Country	Name	City	State
India	Sri Hasanamba Dental College & Hospital	Hassan	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Sri Hasanamba Dental College and Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

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 . — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Clinical attachment level at 3 months in chronic periodontitis patients	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.	3 months