Evaluation of the Controlled Release System of Doxycycline in Periodontal Therapy in Smokers With Chronic Periodontitis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Relative Clinical Attachment Level
研究概览
简要总结
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.
详细描述
VI- Methods
- 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);
- Presence hypersensitivity to tetracyclines and their derivatives;
- Teeth with involvement furcation in the case of premolars.
- Pregnancy and lactation
- Study design
The study will be clinical, randomized, controlled, double-blind, parallel design, and the treatments are randomly distributed among the patients. Selected patients will be divided into 2 groups, whose teeth receive the treatments, as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 59 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients smokers but otherwise healthy
- •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 4 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).
排除标准
- •periapical pulp and 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);
- •Presence hypersensitivity to tetracyclines and their derivatives;
- •Teeth with involvement fork in the case of premolars.
- •Pregnancy and lactation
研究组 & 干预措施
Debridement
mechanical debridement in one session and application of 1 mg placebo microspheres in two periodontal pockts between 5 and 6 mm, and two periodontal pockts greater than or equal to 7 mm
干预措施: Mechanical debridement (Procedure)
Debridement
mechanical debridement in one session and application of 1 mg placebo microspheres in two periodontal pockts between 5 and 6 mm, and two periodontal pockts greater than or equal to 7 mm
干预措施: Placebo (Drug)
Debridement plus Doxycycline
mechanical debridement in one session associated with the application of 1 mg of microspheres loaded with doxycycline per periodontal pockts, two periodontal pockts between 5 and 6 mm, and two periodontal pockts greater than or equal to 7 mm
干预措施: Doxycycline (Drug)
Debridement plus Doxycycline
mechanical debridement in one session associated with the application of 1 mg of microspheres loaded with doxycycline per periodontal pockts, two periodontal pockts between 5 and 6 mm, and two periodontal pockts greater than or equal to 7 mm
干预措施: Mechanical debridement (Procedure)
结局指标
主要结局
Relative Clinical Attachment Level
时间窗: 6 months
Measure of deep periodontal pocket to enamel-cementum junction
次要结局
未报告次要终点
研究者
Enilson Antonio Sallum
Doctor
University of Campinas, Brazil
