Back to resultsAdjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis
Primary Purpose
Aggressive Periodontitis
Status
Completed
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
scaling and systemic moxifloxacin
scaling and root planing
Sponsored by
About this trial
This is an interventional treatment trial for Aggressive Periodontitis focused on measuring Aggressive Periodontitis, antimicrobial(s), microbiology
Eligibility Criteria
Inclusion Criteria:
- under 30 years old and systemically healthy, with at least 20 teeth present. Be willing to participate in the study which is corroborated by signing the informed consent form.
Commit to attend post-therapeutic controls and stop drinking alcohol during the time of ingestion of antibiotics.
Exclusion Criteria:
- Subjects in whom are contraindicated or with hypersensitivity to quinolones - Subjects who have undergone periodontal, surgical or mechanical antibiotic therapy six months before the start of the study according to interrogation.
Women in pregnancy or lactation, corroborated with previous medical history and medical consultation.
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
scaling and root planing
scaling and systemic moxifloxacin
Arm Description
scaling and root planing
scaling and root planing combined with systemic moxifloxacin
Outcomes
Primary Outcome Measures
probing depth
Secondary Outcome Measures
clinical attachment level and probing depth
Full Information
NCT ID
NCT02125812
First Posted
April 25, 2014
Last Updated
May 29, 2014
Sponsor
Facultad Nacional de Salud Publica
Collaborators
Universidad de Antioquia
1. Study Identification
Unique Protocol Identification Number
NCT02125812
Brief Title
Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis
Official Title
Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis: Double-blind Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Facultad Nacional de Salud Publica
Collaborators
Universidad de Antioquia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The adjunctive use of systemically administered antibiotics has been shown to provide a better clinical outcome, particularly in terms of probing depth (PD) reduction and attachment-level gain than SRP in subjects with Aggressive Periodontitis.
The overall objective of this study is to evaluate the clinical and microbiological efficacy of moxifloxacin as an adjunct to scaling and root planing versus scaling and root planing over placebo in the treatment of aggressive periodontitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Periodontitis
Keywords
Aggressive Periodontitis, antimicrobial(s), microbiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
scaling and root planing
Arm Type
Placebo Comparator
Arm Description
scaling and root planing
Arm Title
scaling and systemic moxifloxacin
Arm Type
Experimental
Arm Description
scaling and root planing combined with systemic moxifloxacin
Intervention Type
Other
Intervention Name(s)
scaling and systemic moxifloxacin
Intervention Description
scaling and root planing (SRP) combined with systemic moxifloxacin
Intervention Type
Other
Intervention Name(s)
scaling and root planing
Intervention Description
scaling and root planing
Primary Outcome Measure Information:
Title
probing depth
Time Frame
six months
Secondary Outcome Measure Information:
Title
clinical attachment level and probing depth
Time Frame
6 moths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
under 30 years old and systemically healthy, with at least 20 teeth present. Be willing to participate in the study which is corroborated by signing the informed consent form.
Commit to attend post-therapeutic controls and stop drinking alcohol during the time of ingestion of antibiotics.
Exclusion Criteria:
Subjects in whom are contraindicated or with hypersensitivity to quinolones - Subjects who have undergone periodontal, surgical or mechanical antibiotic therapy six months before the start of the study according to interrogation.
Women in pregnancy or lactation, corroborated with previous medical history and medical consultation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos M Ardila, Ph.D
Organizational Affiliation
Universidad de Antioquia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry
City
Departamento de Antioquia
State/Province
Medellin
Country
Colombia
12. IPD Sharing Statement
Citations:
PubMed Identifier
33197289
Citation
Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.
Results Reference
derived
Links:
URL
http://odontologia.udea.edu.co
Description
Universidad de Antioquia
Learn more about this trial
Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis
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