Evaluation of Local Doxycycline in Smokers With Chronic Periodontitis

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-α. The analysis of the proteolytic enzyme activity is accomplished by using zymography to assess MMP-8 and MMP-9. The described parameters will be evaluated at baseline, 45 and 90 days after the initial visit. The results are compared statistically by analysis of variance with repeated measures with 5% significance level.

Conditions

• Chronic Periodontitis

Interventions

DRUG

Doxycycline

Application of 1 mg of doxyxycline microspheres at 4 sites (two means and two deep periodontal pockets) after mechanical debridement.

PROCEDURE

Mechanical debridement

Mechanical debridement (full mouth) of 45 minutes associated with the application of 1 mg of microspheres placebo in selected periodontal pockets.

DRUG

Placebo

The application of 1 mg of microspheres placebo

Sponsors & Collaborators

• Pontificia Universidade Catolica de Sao Paulo

  collaborator OTHER

• University of Campinas, Brazil

  lead OTHER

Principal Investigators

• Rafaela V Clima da Silva, MD · School of Odontology of Piracicaba - Unicamp

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2016-11-30

Completion

2017-03-31

Countries

• Brazil

Study Locations