Efficacy of Three Antibiotic Protocols for Aggressive Periodontitis Treatment

NCT02839421 | Unknown Phase 4 DMC

• 1 other identifier: 003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Aggressive Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Scaling and Root Planing plus moxifloxacin

EXPERIMENTAL

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 plus amox-metro

ACTIVE COMPARATOR

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 plus placebo

PLACEBO COMPARATOR

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

Interventions

Scaling and Root Planing combined with moxifloxacin DRUG

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

Also known as: periodontal scaling

Scaling and Root Planing plus amox-metro; Scaling and Root Planing plus moxifloxacin; Scaling and Root Planing plus placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Facultad Nacional de Salud Publica: lead

Study Sites (1)

Faculty of Dentistry

Medellín, Antioquia, Colombia

Location

Related Publications (1)

• 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.

  PMID: 34790237 DERIVED

MeSH Terms

Conditions

Aggressive Periodontitis

Interventions

Tooth Exfoliation; Moxifloxacin

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular Professor

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: July 21, 2016
• Study Start: December 1, 2015
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

CO (1)