NCT02016157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

November 6, 2013

Last Update Submit

August 10, 2020

Conditions

Keywords

MoxifloxacinChlorhexidineIn situ gelChronic periodontitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Moxifloxacin, Chronic periodontitis

EXPERIMENTAL

50 micrograms Moxifloxacin

Drug: Moxifloxacin

Interventions

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

Also known as: Avelox
Moxifloxacin, Chronic periodontitis

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sri Hasanamba Dental College & Hospital

Hassan, Karnataka, 573201, India

Location

Related 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.

    PMID: 18834244BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Shaurya Manjunath, MDS

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shaurya Manjunath, Post graduate Student, Department of Periodontology

Study Record Dates

First Submitted

November 6, 2013

First Posted

December 19, 2013

Study Start

September 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 13, 2020

Record last verified: 2020-08

Locations