Efficacy of Three Antibiotic Protocols for Aggressive Periodontitis Treatment

Aggressive Periodontitis Clinical Trial

Official title:

Efficacy of Moxifloxacin, Amoxicillin+Metronidazole for Aggressive Periodontitis Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02839421
• Other study ID #: 003
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2019
• Source: Facultad Nacional de Salud Publica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to evaluate the clinical and microbiological efficacy of moxifloxacin or amoxicillin plus metronidazole in one-stage scaling and root planing in treating generalized aggressive periodontitis. Forty five subjects will be randomly allocated to 3 treatment groups. Subgingival plaque samples will be analysed for cultivable bacteria. The primary outcome variable to determine the superiority of one treatment over the others would be differences between groups for means CAL changes at 6 months post-treatment. Secondary outcome variables include differences between therapies for the mean changes in the mean levels of PD and the proportion of BOP.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Subjects =30 years of age

• minimum of six permanent teeth, with at least one site each with probing depth (PD) and clinical attachment level (CAL) =5 mm and a minimum of six teeth other than first molars and incisors with at least one site each with PD and CAL =5 mm.

Exclusion Criteria:

• diabetes

• cardiovascular diseases

• immunological disorders or any other systemic disease that could alter the course of periodontal disease.

• Pregnant or nursing women

• smoking

• allergy to amoxicillin, metronidazole, fluoroquinolones or moxifloxacin

• consumption of systemic antimicrobials or anti-inflammatory drugs in the last 6 months

• periodontal therapy during the last 6 months

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Periodontitis

Intervention

Drug:
• Scaling and Root Planing combined with moxifloxacin
Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days

Locations

Country	Name	City	State
Colombia	Faculty of Dentistry	Medellín	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Facultad Nacional de Salud Publica

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical attachment level	It was defined that the primary outcome variable to determine the superiority of one treatment over the other would be differences between groups for means Clinical Attachment Level changes at 6 months post-treatment. This is a measure assessing change between two time points .	3 and 6 months