Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis
Condition: Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Interventional
Phase: Phase 2/Phase 3

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 description: 
      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 depth (PD): distance from the bottom of sulcus/pocket
      to gingival margin; 4) Gingival recession (GM): distance from the free gingival margin to
      cement-enamel junction (CEJ); 5) Clinical attachment level (CAL): distance from bottom of
      sulcus/pocket to the CEJ. The CEJ will be identified by careful probe on cervical area.

      Calibration and Randomization

      Initially, a total of ten patients presenting with GAgP will be selected. The designated
      examiner (CFA) will measure CAL and PD in all patients twice within 24 hours, with an
      interval of ≥ 1 hour between examinations. Then, the measures will be submitted to intraclass
      correlation test and the examiner will be judged calibrated if reaches 90% agreement.

      Patients will be allocated into two groups according to a computer-generated list. The
      allocation will be implemented by an investigator (NCCS) who was not directly involved in the
      examination or treatment procedures. All medication will be prepared and encased in identical
      opaque coded bottles by a manipulation pharmacy on São José dos Campos/São Paulo.

      Treatment Protocols

      All patients will be treated with periodontal therapy through of the one-stage, full mouth,
      ultrasonic debridement (FMUD). In a single session, patients will receive local anesthesia
      and periodontal debridement with ultrasound equipment (Cavitron - Dentsply EUA) and
      subgingival tips (UI25KSF10S, Hu-Friedy). All diseased sites will be instrumented in this one
      session. The debridement session will be performed by a single experienced and trained
      periodontist (MPS), different from the examiner. Immediately before the mechanical therapy,
      patients will be allocated in one of the two treatment protocols:

        1. Clarithromycin (CLM) group (n = 22): FMUD + CLM 500 mg bid, for 7 days and

        2. Amoxicillin (AMX) + metronidazole (MET) group (n = 22): FMUD + (AMX 500 mg tid + MET 400
           mg tid, both for 7 days.

      All patients will start taking the pills immediately before of the FMUD session.

      Compliance and Adverse Effects

      After 7 days of periodontal treatment, patients will be asked to return any medication not
      taken and/or the empty bottles. The number of pills not taken by the subject will be
      documented. Moreover, patients will be instructed to return a self-report form filled about
      any possible adverse effects in order to help evaluate their adherence to the systemic
      antimicrobial regimen.

      Statistical analysis

      Mean and standard deviation will be calculated for each parameter. The normal distribution of
      the data will be analyzed by Shapiro-Wilk test. Data from clinical measurements will be
      subjected to analysis of variance (repeated measures) for inter and intra-group comparison.
    

Intervention name(s): Full-mouth ultrasonic debridement; Clarithromycin; Amoxicillin; Metronidazole
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention description(s): Full-mouth ultrasonic debridement will be performed in order to treat diseased sites; Administration of Clarithromycin 500mg bid for 7 days; Administration of Amoxicillin 500mg tid for 7 days.; Administration of Metronidazole 400mg tid for 7 days.
Other intervention name(s): Periodontal debridement; Biaxin; Amoxil; Flagyl
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Full-mouth ultrasonic debridement; Clarithromycin; Amoxicillin; Metronidazole