Clinical Trial: Periodontal Debridement Associated With Systemic Antibiotics and Single/Repeated PDT to Treat Aggressive Periodontitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Local Effect of Periodontal Debridement Associated With Different Systemic Antibiotic Protocols and Single or Repeated Application of Photodynamic Therapy to Treat Generalized Ag

Brief Summary: The aim of this project is to compare the efficacy and the local effect of the association of single or repeated application of photodynamic therapy (PDT) with antibiotic agents using Amoxicillin + Metronidazole or Clarithromycin in the treatment of patients with Generalized Aggressive Periodontitis (GAgP).

Detailed Summary:

The study methodology is according to CONSORT-STATEMENT 2010 and SPIRIT 2013 for randomized controlled clinical trials.

Study Design

The study is designed as a prospective, interventional, parallel, blinded, randomized, controlled clinical trial aimed to compare the efficacy and the local effect of the association of single or repeated application of photodynamic therapy (PDT) with antibiotic agents using Amoxicillin + Metronidazole or Clarithromycin in the treatment of patients with Generalized Aggressive Periodontitis (GAgP).

Source of data

The population of this study will be recruited among patients referred to the Science and Technology Institute (ICT) - São José dos Campos, College of Dentistry. Each one of 46 patients will have three pockets with probing depth and loss of clinical attachment level ≥5 mm and bleeding on probing not located at furcation sites randomly chosen.

Power calculation

A population of 46 patients (138 periodontal pockets, 3 per patient) that meet the pre-established criteria will be considered. Considering α = 5% and a β = 5% to detect a difference of 1 mm between groups in probing depth reduction of pockets ≥5 mm, for a standard deviation of 0.8 mm, 14 patients will be needed in each group. With a sample of 46 patients (138 pockets), the study will have a power greater than 95%.

Clinical Parameters

All clinical parameters will be assessed by a single blinded, trained and calibrated examiner (CFA) before periodontal therapy (baseline) and at 3 and 6 months after using
Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

Current Primary Outcome: Change in Probing Depth (PD) [ Time Frame: 0, 3 and 6 post-operatively ]

Evaluate the difference between baseline and 6 months PD measures.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universidade Estadual Paulista Júlio de Mesquita Filho

Dates:
Date Received: April 23, 2017
Date Started: March 2015
Date Completion:
Last Updated: April 26, 2017
Last Verified: April 2017