Efficacy of Three Antibiotic Protocols for Aggressive Periodontitis Treatment

Efficacy of Moxifloxacin, Amoxicillin+Metronidazole for Aggressive Periodontitis Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Aggressive Periodontitis
• Intervention / Treatment: Drug: Scaling and Root Planing combined with moxifloxacin

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia
      • Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scaling and Root Planing plus 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.	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; Other Names: periodontal scaling
Active Comparator: Scaling and Root Planing plus amox-metro; 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; Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days; Other Names: periodontal scaling
Placebo Comparator: Scaling and Root Planing plus placebo; 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; Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days; 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

Collaborators and Investigators

• Sponsor: Facultad Nacional de Salud Publica

Publications and helpful links

General Publications

• Hammami C, Nasri W. Antibiotics in the Treatment of Periodontitis: A Systematic Review of the Literature. Int J Dent. 2021 Nov 8;2021:6846074. doi: 10.1155/2021/6846074. eCollection 2021.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): May 31, 2019
• Study Completion (Anticipated): May 31, 2019

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 27, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Aggression; Periodontitis; Aggressive Periodontitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: 003 (033)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED