Clinical Trial: Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis

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

Official Title: Full-mouth Periodontal Debridement Associated With Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial

Brief Summary: The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP).

Detailed Summary:

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

Study Design

The study is designed as a prospective, interventional, parallel, triple blind, randomized, controlled clinical trial aimed to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP). The study was approved by Institute of Science and Technology's (ICT - State University of São Paulo) Ethics Committee (protocol 1.079.307).

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. Patients will fill a healthy history questionnaire to ensure that they are medically qualified for participate in this study. Based on the power calculation for this study, 44 subjects divided into two groups will be needed to achieve 80% power to detect a 0.8 mm difference in the clinical attachment level (CAL) of patients.

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 a manual probe. Measurements will be done at six sites per tooth (mesiobuccal, buccal, disto-buccal, distolingual, lingual, and mesiolingual) in all teeth, except third molars.

The following clinical parameters will be evaluated: 1) Full-mouth plaque index (FMPI); 2) Bleeding on probing (BoP); 3) Probing
Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

Current Primary Outcome: Change in clinical attachment level (CAL) [ Time Frame: Baseline, 3 and 6 months ]

Evaluate the difference between baseline and 6 months CAL measures.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in probing depth (PB) [ Time Frame: Baseline, 3 and 6 months ]
    Evaluate the difference between baseline and 6 months PB measures.
  • Change in bleeding on probe (BoP) [ Time Frame: Baseline, 3 and 6 months ]
    Evaluate the difference between baseline and 6 months BoP measures.


Original Secondary Outcome: Same as current

Information By: Universidade Estadual Paulista Júlio de Mesquita Filho

Dates:
Date Received: November 7, 2016
Date Started: March 2015
Date Completion:
Last Updated: April 23, 2017
Last Verified: April 2017