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Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis

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ClinicalTrials.gov Identifier: NCT02125812
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : June 2, 2014
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Carlos Martin Ardila Medina, Universidad de Antioquia

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.


Condition or disease Intervention/treatment Phase
Aggressive Periodontitis Other: scaling and systemic moxifloxacin Other: scaling and root planing Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis: Double-blind Controlled Clinical Trial
Study Start Date : August 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

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Arm Intervention/treatment
Placebo Comparator: scaling and root planing
scaling and root planing
Other: scaling and root planing
scaling and root planing

Experimental: scaling and systemic moxifloxacin
scaling and root planing combined with systemic moxifloxacin
Other: scaling and systemic moxifloxacin
scaling and root planing (SRP) combined with systemic moxifloxacin




Primary Outcome Measures :
  1. probing depth [ Time Frame: six months ]

Secondary Outcome Measures :
  1. clinical attachment level and probing depth [ Time Frame: 6 moths ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125812


Locations
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Colombia
Faculty of Dentistry
Departamento de Antioquia, Medellin, Colombia
Sponsors and Collaborators
Facultad Nacional de Salud Publica
Universidad de Antioquia
Investigators
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Principal Investigator: Carlos M Ardila, Ph.D Universidad de Antioquia

Additional Information:
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Responsible Party: Carlos Martin Ardila Medina, Titular Professor, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT02125812     History of Changes
Other Study ID Numbers: 002
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Keywords provided by Carlos Martin Ardila Medina, Universidad de Antioquia:
Aggressive Periodontitis
antimicrobial(s)
microbiology
Additional relevant MeSH terms:
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Aggressive Periodontitis
Norgestimate, ethinyl estradiol drug combination
Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs