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Moxifloxacin in Situ Gel to Treat Periodontal Pocket.

Primary Purpose

Chronic Generalized Periodontitis

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Moxifloxacin
Sponsored by
Sri Hasanamba Dental College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Generalized Periodontitis focused on measuring Moxifloxacin, Chlorhexidine, In situ gel, Chronic periodontitis

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sri Hasanamba Dental College & Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Moxifloxacin, Chronic periodontitis

Arm Description

50 micrograms Moxifloxacin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2013
Last Updated
August 10, 2020
Sponsor
Sri Hasanamba Dental College and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02016157
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sri Hasanamba Dental College and Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Generalized Periodontitis
Keywords
Moxifloxacin, Chlorhexidine, In situ gel, Chronic periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moxifloxacin, Chronic periodontitis
Arm Type
Experimental
Arm Description
50 micrograms Moxifloxacin
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
Avelox
Intervention Description
TO ASSESS THE EFFICACY OF MOXIFLOXACIN IN SITU GEL IN THE TREATMENT OF PERIODONTAL POCKET.
Primary Outcome Measure Information:
Title
Change from baseline in Clinical attachment level at 3 months in chronic periodontitis patients
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaurya Manjunath, MDS
Organizational Affiliation
Rajiv Gandhi University of Health Sceinces, Bangalore,Karnataka, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sri Hasanamba Dental College & Hospital
City
Hassan
State/Province
Karnataka
ZIP/Postal Code
573201
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
18834244
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.
Results Reference
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Moxifloxacin in Situ Gel to Treat Periodontal Pocket.

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