Clinical and Microbiological Evaluation of Non-surgical Periodontal Treatment of Diabetic and Non-diabetic Patients: A Longitudinal Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Percentage of bleeding on probing
研究概览
简要总结
The purpose of this study is to determine whether periodontal treatment improves the periodontal clinical parameters in the periodontal patients with diabetes regarding non-diabetics: two years follow-up.
详细描述
All the subjects in the study will receive non surgical periodontal treatment in one session (full-mouth scaling and root planing). Clinical parameters will be assessed in all teeth (except third molars) by one experienced and trained examiner before treatment and every 3 months for 2 years. Visible plaque index (VPI) will be represented a mean percentage of sites with visible plaque calculated for all teeth analyzed (four sites per tooth). Others parameters will be assessed at six sites per tooth using a manual periodontal probe (15mm). Bleeding on probing (BOP) will be represented the mean percentage of sites with bleeding (up to 15 seconds after probing) calculated for all teeth analyzed. Probing depth (PD - distance between the gingival margin and the bottom of the sulcus/pocket), gingival recession (GR - distance between the cementoenamel junction and gingival margin) and clinical attachment level (CAL - distance between the cementoenamel junction and the bottom of the sulcus/pocket) will be represented a mean distance calculated per site for all teeth analyzed. For blood parameters, an outside laboratory will perform all blood analysis. It will be requested for each subject with diabetes (DG) at baseline, each 3 months post-treatment. Fasting plasma glucose (FPG) will be expressed in milligrams per deciliter and HbA1c will be expressed as a percentage. Statistical analysis will be performed using an available software program and the patient will be considered as the unit of analysis.The data will be processed and analyzed by descriptive and inferential statistics, probably nonparametric.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronical periodontitis according to Lopez et al. 2002 (one or more teeth with at least one site with PD >= 4mm or CAL >= 3mm);
- •And have at least 8 natural teeth (excluding third molars), and older than 18 years and of both genders.
排除标准
- •Any systemic diseases or complications (except Type 2 Diabetes Mellitus) such as cardiovascular disease, Alzheimer's, lung or brain diseases and metabolic syndrome;
- •Use of antibiotics or periodontal treatment within the past 6 months;
- •Long-term administration of anti-inflammatory or/and immunosuppressive agents;
- •Current smoker or former smoker for the past 5 years;
- •Pregnant or breastfeeding;
- •And presence of orthodontic appliances.
结局指标
主要结局
Percentage of bleeding on probing
时间窗: at twenty four months
The mean percentage of periodontal sites with bleeding on probing
次要结局
- Probing depth (mm)(Baseline and at three, six, nine, twelve, eighteen and twenty four months)
- Percentage of visible plaque index(Baseline and at three, six, nine, twelve, eighteen and twenty four months)
- Clinical attachment level (mm)(Baseline and at three, six, nine, twelve, eighteen and twenty four months)
研究者
Eduardo Aleixo Figueira
DDS, MSc, PhD, Post-Doctoral Student
Universidade Federal do Rio Grande do Norte