Efficacy of Three Antibiotic Protocols for Aggressive Periodontitis Treatment

Study Overview
=================
Brief 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.

Official Title
-----------------
Efficacy of Moxifloxacin, Amoxicillin+Metronidazole for Aggressive Periodontitis Treatment

Conditions
-----------------
Aggressive Periodontitis

Intervention / Treatment
-----------------
* Drug: Scaling and Root Planing combined with moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scaling and Root Planing plus moxifloxacin<br>The interventions are Scaling and Root Planing (SRP) combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days.The experimental treatment group consist of SRP combined with systemically administered MOX at the dosage of 400 mg once daily for 7 days.One-stage full-mouth SRP under local anesthesia will be performed (using manual instruments and ultrasonic debridement) in approximately 2 h and half by the same experienced clinician.The endpoint of SRP will be a tactile smooth root surface. The adjunctive agent will start at the SRP visit. Subjects in the MOX group will be extensively informed about the intake of the prescribed medication. | Drug: Scaling and Root Planing combined with moxifloxacin<br>* Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days<br>* Other names: periodontal scaling;|
| Active Comparator: Scaling and Root Planing plus amox-metro<br>The active comparator is Scaling and Root Planing (SRP) combined with systemically administered Amoxicillin (amox) + Metronidazole (metro) 500 mg tid each one for 7 days. The active comparator group consist of SRP combined with systemically administered Amoxicillin (amox) + Metronidazole (metro) 500 mg tid each one for 7 days. One-stage full-mouth SRP under local anesthesia will be performed (using manual instruments and ultrasonic debridement) in approximately 2 h and half by the same experienced clinician.The endpoint of SRP will be a tactile smooth root surface. The adjunctive agent will start at the SRP visit. Subjects in the amox-metro group will be extensively informed about the intake of the prescribed medication. | Drug: Scaling and Root Planing combined with moxifloxacin<br>* Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days<br>* Other names: periodontal scaling;|
| Placebo Comparator: Scaling and Root Planing plus placebo<br>Scaling and Root Planing (SRP) + placebo once daily for 7 days. The placebo comparator group consist of SRP combined with systemically administered placebo once daily for 7 days. One-stage full-mouth SRP under local anesthesia will be performed (using manual instruments and ultrasonic debridement) in approximately 2 h and half by the same experienced clinician.The endpoint of SRP will be a tactile smooth root surface. The placebo agent will start at the SRP visit. Subjects in the placebo group will be extensively informed about the intake of the prescribed medication. | Drug: Scaling and Root Planing combined with moxifloxacin<br>* Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days<br>* Other names: periodontal scaling;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |