Clinical Trial: Evaluation of Local Doxycycline in Smokers With Chronic Periodontitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of the Controlled Release System of Doxycycline in Periodontal Therapy in Smokers With Chronic Periodontitis.

Brief Summary: Summary The aim of this study is to evaluate through clinical, microbiological and immunological parameters using PLGA microspheres (lactic-co-glycolic acid polyacid) containing doxycycline in periodontal therapy in smokers with chronic periodontitis. For this study, 40 patients will be selected, with an average age between 30 and 59 years old of both genders (male and female), who spontaneously seek the clinic graduate of the Piracicaba Dental School -FOP / UNICAMP, and exhibiting at least four bleeding sites, including 2 sites with a probing depth (PD) between 5 and 6 mm and two sites PS ≥7 mm in uniradiculares teeth. Patients should have a minimum of 20 teeth. Will be excluded from relevant systemic disease carriers or antibiotics used in the 6 months preceding the study. All patients will receive oral hygiene instruction and will undergo a pre-treatment, which will be held supragingival sweeps and removal of plaque retentive factors. Patients will be divided into 2 groups (DB + DOX: Debridement + Doxycycline, test group and DB: only debridement, control group) of 20 patients who will receive the following treatments: periodontal debridement ultrasound for 45 minutes associated with the local administration of 1 mg microspheres containing doxycycline, or just mechanical debridement, for each selected site. Will be assessed the following clinical parameters: gingival index (GI) Plaque Index (PI), Bleeding on Probing (BOP), Position of the gingival margin (PGM), Probing Depth (PD) and Relative Clinical Attachment Level (RCAL). The microbiological evaluation will be made by means of polymerase chain reaction - real time ( "real time" - PCR) to detect bacteria: Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Aggregatibacter actinomycetemcomitans and Prevotella intermedia. The enzyme immunoassay (LUMINEXMAGPIX) allow the detection of cytokine levels of GM-CSF, INF-γ, IL-10, IL-12, IL-13, IL-1β, IL-4, IL-6, IL-8 and TNF-&#

Detailed Summary:

VI- Methods

  1. Sample Selection

    After submission and approval of this project to the Research Ethics Committee (CEP) of the Piracicaba Dental School - UNICAMP, will be selected among the patients who seek spontaneously treatment in clinics Graduate FOP-UNICAMP (where also will be performed the clinical phase of the study), 40 patients with an average age between 30 and 59 years, of both genders (male or female) according to the following inclusion criteria:

    • Patients smokers, but overall good health
    • patients initially diagnosed with moderate or severe chronic periodontitis (according to the American Academy of Periodontology- AAP, 1999) verified the presence of radiographic periodontal pockets and bone loss;
    • Patients who have at least four bleeding sites with probing depth (PD)> 5 mm in uniradiculares teeth.
    • Presence of a minimum of 20 teeth;
    • formal consent to participate in research, after explaining the risks and benefits for individual not involved in it. (Resolution No. 196 of October 1996 and the Dental Code of Professional Ethics (C.F.O.) 179/93).

    The exclusion criteria are:

    • periapical or pulp change Presence
    • Presence of systemic changes or use of medications (6 months prior to the study) that may influence response to periodontal treatment (eg, phenytoin, cyclosporine, calcium channel antagonists, and anti-inflammatory steroids and non-steroidal); Sponsor: University of Campinas, Brazil

      Current Primary Outcome: Relative Clinical Attachment Level [ Time Frame: 6 months ]

      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: University of Campinas, Brazil

      Dates:
      Date Received: February 29, 2016
      Date Started: June 2015
      Date Completion: March 2017
      Last Updated: January 16, 2017
      Last Verified: October 2016