Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis

NCT ID: NCT02125812

Last Updated: 2014-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aggressive Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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scaling and root planing

scaling and root planing

Group Type PLACEBO_COMPARATOR

scaling and root planing

Intervention Type OTHER

scaling and root planing

scaling and systemic moxifloxacin

scaling and root planing combined with systemic moxifloxacin

Group Type EXPERIMENTAL

scaling and systemic moxifloxacin

Intervention Type OTHER

scaling and root planing (SRP) combined with systemic moxifloxacin

Interventions

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scaling and systemic moxifloxacin

scaling and root planing (SRP) combined with systemic moxifloxacin

Intervention Type OTHER

scaling and root planing

scaling and root planing

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Antioquia

OTHER

Sponsor Role collaborator

Facultad Nacional de Salud Publica

OTHER

Sponsor Role lead

Responsible Party

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Carlos Martin Ardila Medina

Titular Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos M Ardila, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Locations

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Faculty of Dentistry

Departamento de Antioquia, Medellin, Colombia

Site Status

Countries

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Colombia

References

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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.

Reference Type DERIVED
PMID: 33197289 (View on PubMed)

Related Links

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http://odontologia.udea.edu.co

Universidad de Antioquia

Other Identifiers

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002

Identifier Type: -

Identifier Source: org_study_id

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