The Impact of Enamel Matrix Derivatives on Periodontal Healing in Diabetic Patients After Non-Surgical Periodontal Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Pocket probing depth (PPD)
研究概览
简要总结
The aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of periodontal healing in diabetic patients.
详细描述
Patients with periodontitis will be randomly allocated to two groups. In both groups, periodontal root instrumentation will be performed. In the test group, an additional flapless application of enamel matrix derivatives will be granted for sites with pockets deeper than 5 mm.
Metabolic glucose control as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Opaque envelopes
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with diabetes mellitus type II and currently under treatment;
- •No previous periodontal treatment in the last 6 months;
- •Presence of Periodontitis (Clinical attachment loss of at least 3 mm in 2 or more non- adjacent teeth);
- •Ability to understand the study procedures and comply with them through the length of the study.
排除标准
- •Pregnancy and breast feeding;
- •Need for antibiotic treatment during periodontal therapy;
- •Chronic infections;
- •Systemic diseases;
- •Patients who report current smoking over 20 cigarettes per day.
结局指标
主要结局
Pocket probing depth (PPD)
时间窗: Measured at Baseline and 3 months after treatment
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
次要结局
- Number of sites with Pocket probing depth deeper than 5mm(Measured at Baseline and 3 months after treatment)
- Full-mouth plaque score (FMPS)(Measured at Baseline and 3 months after treatment)
- Oxford Happiness Questionnaire (OHQ)(Measured at Baseline and 3 months after treatment)
- Glycated Hemoglobin (HbA1c)(Measured at Baseline and 3 months after treatment)
- Clinical attachment level (CAL)(Measured at Baseline and 3 months after treatment)
- Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline(Measured at Baseline and 3 months after treatment)
- Oral Health Index Profile-14 (OHIP-14)(Measured at Baseline and 3 months after treatment)
- High sensitivity C-Reactive Protein (hsCRP)(Measured at Baseline and 3 months after treatment)
- Recession of the gingival margin (REC)(Measured at Baseline and 3 months after treatment)
- Percentage of sites with Pocket probing depth deeper than 5mm(Measured at Baseline and 3 months after treatment)
- Full-mouth bleeding score (FMBS)(Measured at Baseline and 3 months after treatment)
研究者
Filippo Graziani, DDS MClinDent PhD
Full Professor
University of Pisa