Evaluation of Local Doxycycline in Smokers With Chronic Periodontitis
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
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.