Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects: Clinical, Immunological and Microbiological Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Changes in clinical attachment level (CAL) in sites with initial PD ≥7mm from baseline to 12 months.
研究概览
简要总结
The aim of this study will be to evaluate: 1- the effect of full-mouth (FM) scaling and root (SRP) planing in 24 hours associated with or without extensive application of chlorhexidine (CLX) on clinical, microbiological, glycemic and immunological parameters in diabetic subjects with chronic periodontitis at 3, 6 and 12 months post-therapy. The hypothesis is that FMSRP associated with CLX use will provide the best clinical, microbiological, glycemic and immunological outcomes for the treatment of diabetic subjects with periodontitis. Sixty diabetic subjects with chronic periodontitis will be divided in the following therapeutic groups (n=20 subjects per group): FMSRP+CLX group - FMSRP in a maximum of 24 hours, application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution during 60 days; FMSRP + placebo group - FMSRP in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days; Partial-mouth (PM) SRP group: SRP in 4-6 sessions in a maximum of 2 weeks. The following clinical parameters will be evaluated at 3, 6 and 12 months post-therapy: plaque accumulation, gingival bleeding, probing depth, clinical attachment level, bleeding on probing and suppuration. At these same periods, glycated hemoglobin levels will be obtained from all subjects. In addition, six subgingival biofilm samples per subject will be analyzed by checkerboard DNA-DNA hybridization for 40 bacterial species at baseline, 3, 6 and 12 post-therapy. Finally, gingival crevicular fluid samples from two shallow and two deep sites will be evaluated for the levels of cyto/chemokines by ELISA. Data will be submitted to appropriate statistical analysis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 2 diabetes mellitus
- •Clinical diagnosis of generalized chronic periodontitis
- •> 30 years old
- •At least 15 teeth excluding third molars and teeth indicated to exodontia
- •More than 30% of the sites with probing depth and clinical attachment level ≥ 4 mm at baseline
排除标准
- •Pregnancy
- •Lactation
- •Current smoking
- •Smoking within the past 5 years
- •Periodontal or/and antibiotic therapies in the previous 6 months
- •Regular use of mouthrinses containing antimicrobials in the preceding 2 months
- •Other systemic condition that could affect the progression of periodontal disease
- •Long-term use of anti-inflammatory and immunosuppressive medications
- •Presence of periapical pathology
- •Use of orthodontic appliances
- •Multiple systemic complications of DM.
研究组 & 干预措施
FMSRP+CLX
Full-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution during 60 days
干预措施: FMSRP (Procedure)
FMSRP+CLX
Full-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution during 60 days
干预措施: Chlorhexidine (Drug)
FMSRP + placebo group
Full-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days
干预措施: FMSRP (Procedure)
FMSRP + placebo group
Full-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days
干预措施: Placebo (Other)
PMSRP group
Partial-mouth scaling and root planing in 4-6 sessions in a maximum of 2 weeks
干预措施: PMSRP (Procedure)
结局指标
主要结局
Changes in clinical attachment level (CAL) in sites with initial PD ≥7mm from baseline to 12 months.
时间窗: From baseline to 12 months
次要结局
- Changes in percentage of sites with probing depth ≥5mm(From baseline to 12 months)
- Changes in serum levels of glycemic hemoglobin(From baseline to 12 months)
- Changes in the counts of pathogenic bacterial species(From baseline to 12 months)
- Changes in the levels of tumor necrosis factor-α in gingival crevicular fluid(From baseline to 12 months)
- Changes in the levels of plaque accumulation(From baseline to 12 months)
- Changes in the mean percentage of sites with bleeding on probing(From baseline to 12 months)
- Changes in the full-mouth probing depth(From baseline to 12 months)
- Changes in the serum levels of fasting plasma glucose(From baseline to 12 months)
- Changes in the proportions of pathogenic bacterial species(From baseline to 12 months)
- Changes in the levels of interferon (IFN)-γ in gingival crevicular fluid(From baseline to 12 months)
- Changes in the levels of interleukin (IL)-17 in gingival crevicular fluid(From baseline to 12 months)
- Changes in the levels of IL-23 in gingival crevicular fluid(From baseline to 12 months)
- Changes in the levels of IL-4 in gingival crevicular fluid(From baseline to 12 months)
- Changes in levels of receptor activator of NF-κß ligand (RANKL) in gingival crevicular fluid(From baseline to 12 months)
- Changes in the levels of osteoprotegerin (OPG) in gingival crevicular fluid(From baseline to 12 months)
研究者
Poliana Mendes Duarte
PhD
University of Guarulhos