Efficacy of Three Antibiotic Protocols for Aggressive Periodontitis Treatment

Phase 4

• Conditions: Aggressive Periodontitis
• Interventions: Drug: Scaling and Root Planing combined with moxifloxacin

• Registration Number: NCT02839421
• Lead Sponsor: Facultad Nacional de Salud Publica

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-27
• Last Update Posted: 2019-05-29
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling and Root Planing plus moxifloxacin	Scaling and Root Planing combined with moxifloxacin	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.
Scaling and Root Planing plus amox-metro	Scaling and Root Planing combined with moxifloxacin	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.
Scaling and Root Planing plus placebo	Scaling and Root Planing combined with moxifloxacin	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.

Primary Outcome Measures

Name	Time	Method
clinical attachment level	3 and 6 months	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 .

Trial Locations

Locations (1)

Faculty of Dentistry; 🇨🇴 Medellín, Antioquia, Colombia