Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis

Aggressive Periodontitis Clinical Trial

Official title:

Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis: Double-blind Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125812
• Other study ID #: 002
• Status: Completed
• Phase: Phase 4
• First received: April 25, 2014
• Last updated: May 29, 2014
• Start date: August 2011
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Facultad Nacional de Salud Publica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 30 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Colombia	Faculty of Dentistry	Departamento de Antioquia	Medellin

Sponsors (2)

Lead Sponsor	Collaborator
Facultad Nacional de Salud Publica	Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	probing depth		six months	No
Secondary	clinical attachment level and probing depth		6 moths	No

External Links

•   Universidad de Antioquia