Clinical trial NCT02016157: Moxifloxacin in Situ Gel to Treat Periodontal Pocket.
Official title: Moxifloxacin In Situ Gel as an Adjunct in the Treatment of Periodontal Pocket: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Generalized Periodontitis
Keywords: Moxifloxacin
Chlorhexidine
In situ gel
Chronic periodontitis
Lead sponsor: Sri Hasanamba Dental College and Hospital
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 5
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in Clinical attachment level at 3 months in chronic periodontitis patients
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hassan
country: India
facility: Sri Hasanamba Dental College & Hospital
state: Karnataka
Study officials:
affiliation: Rajiv Gandhi University of Health Sceinces, Bangalore,Karnataka, India
name: Shaurya Manjunath, MDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.