Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 25, 2014
CompletedFirst Posted
Study publicly available on registry
April 29, 2014
CompletedJune 2, 2014
May 1, 2014
2.6 years
April 25, 2014
May 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
probing depth
six months
Secondary Outcomes (1)
clinical attachment level and probing depth
6 moths
Study Arms (2)
scaling and root planing
PLACEBO COMPARATORscaling and root planing
scaling and systemic moxifloxacin
EXPERIMENTALscaling and root planing combined with systemic moxifloxacin
Interventions
scaling and root planing (SRP) combined with systemic moxifloxacin
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Facultad Nacional de Salud Publicalead
- Universidad de Antioquiacollaborator
Study Sites (1)
Faculty of Dentistry
Departamento de Antioquia, Medellin, Colombia
Related Publications (1)
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.
PMID: 33197289DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos M Ardila, Ph.D
Universidad de Antioquia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Titular Professor
Study Record Dates
First Submitted
April 25, 2014
First Posted
April 29, 2014
Study Start
August 1, 2011
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
June 2, 2014
Record last verified: 2014-05