Professional and Home Oral Care With Non Surgical Periodontal Therapy for the Evaluation of Glycosylated Hemoglobin (HbA1c) in Patients Suffering From Diabetes Mellitus Type 1: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Glycosylated Hemoglobin (HbA1c)
研究概览
简要总结
The aim of this study is to evaluate the efficacy of Peribioma Toothpaste and Mousse for home oral care in patients with Diabetes Mellitus Type 1.
Patients will undergo a professional oral hygiene procedure, followed by irrigation with ozonized water.
Patients will be randomly divided into two groups:
- Trial Group: patients will use Biorepair Peribioma Toothpaste and Mousse for home oral care
- Control Group: patients will use Biorepair Plus Parodontgel toothpaste for home oral care.
The variations of the following indices will be evaluated at the baseline, after 3 and 6 months: glycosylated hemoglobin (HbA1c) , Clinical Attachment Level (CAL), Plaque Index (PI), Probing Pocket Depth (PPD) and Bleeding on Probing (BoP).
详细描述
The aim of this study is to evaluate the efficacy of Peribioma Toothpaste and Mousse for home oral care in patients with Diabetes Mellitus Type 1.
Patients who respond to eligibility criteria and that will sign the informed consent will undergo a professional oral hygiene procedure; then, ozonized water (aquolab) will be used to irrigate periodontal pockets for 1 minute.
Then, patients will be randomly divided into two groups:
- Trial Group: patients will use Biorepair Peribioma Toothpaste and Mousse for home oral care until the end of the study;
- Control Group: patients will use Biorepair Plus Parodontgel toothpaste for home oral care until the end of the study.
Changes in the following indices will be evaluated at the baseline, after 3 and 6 months: glycosylated hemoglobin (HbA1c) , Clinical Attachment Level (CAL), Plaque Index (PI), Probing Pocket Depth (PPD) and Bleeding on Probing (BoP).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering from Diabetes Mellitus Type 1
- •adult patients
- •patients who agreed to participate to the study and that signed the informed consent.
排除标准
- •patients taking intravenous or oral Bisphosphonates at the study begin or in the previous 12 months
- •patients with low compliance and motivation to participate
- •pazienti irradiati alla testa o collo negli ultimi 12 mesi
- •pregnant or breastfeeding women
- •alcohol and drug abuse
- •patients with psychiatric diseases
结局指标
主要结局
Change in Glycosylated Hemoglobin (HbA1c)
时间窗: Baseline, 3 and 6 months.
Serum levels of glycosylated hemoglobin
Change in CAL - Clinical Attachment Loss
时间窗: Baseline, 3 and 6 months.
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Change in BOP - Bleeding on Probing (percentage)
时间窗: Baseline, 3 and 6 months.
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. Percentage of sites with bleeding on probing determines the BOP%.
Change in PI - Plaque Index (Silness and Löe, 1964)
时间窗: Baseline, 3 and 6 months.
Scoring criteria: 0 = no plaque; 1. = thin plaque layer at the gingival margin, only detectable by scraping with a probe; 2. = moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye; 3. = abundant plaque along the gingival margin; interdental spaces filled with plaque.
Change in PPD - Probing Pocket Depth
时间窗: Baseline, 3 and 6 months.
Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.
次要结局
未报告次要终点
研究者
Andrea Scribante
Research Resident, Principal Investigator
University of Pavia