Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis

Sponsor

Facultad Nacional de Salud Publica (Other)

Overall Status

Completed

CT.gov ID

NCT02125812

Collaborator

Universidad de Antioquia (Other)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

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 :

Aug 1, 2011

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

probing depth [six months]

Secondary Outcome Measures

clinical attachment level and probing depth [6 moths]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.