Epidemiology, Clinical Evaluation of Black Stains and Patients' Dietary Habits: a Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in the extension of black stains (Gasparetto et al., 2003)
研究概览
简要总结
The aim of this study is to investigate epidemiology and treatment possibilities of black stains, with the assessment of a possible correlation with patients' dietary habits.
Patients will be randomly divided into three groups. For each group, clinical evaluation will be performed at the study begin, after 2 and after 6 months.
At the study begin, evaluation of black stains with Gasparetto's classification will be assessed; then professional oral hygiene with ultrasonic scaler will be performed, plus glycine and polish; then, products for home oral care will be given to patients, depending on the groups. The clinical situation will be re-evaluated after 2 and after 6 months. Home oral care will be performed with different products, containing lactoferrin (group 1) and probiotics (group 2). The control group (Group 3) will use normal products.
详细描述
The aim of this study is to investigate epidemiology and treatment possibilities of black stains, with the assessment of a possible correlation with patients' dietary habits.
Patients will be randomly divided into three groups. For each group, clinical evaluation will be performed at the study begin, after 2 and after 6 months.
At the study begin, evaluation of black stains with Gasparetto's classification will be assessed; then professional oral hygiene with ultrasonic scaler will be performed, plus glycine and polish; then, products for home oral care will be given to patients, depending on the groups. The clinical situation will be re-evaluated after 2 and after 6 months.
Home oral care will be performed as follows:
- Group 1: patients will use 2 Forhans GengiFor tables (between foods) and Forhans Scudo Naturale toothpaste containing lactoferrin.
- Group 2: patients will use Biorepair Peribioma chewing-gum for 10 minutes/day and Biorepair Peribioma toothpaste containing probiotics.
- Group 3: patients will choose the best product for their home oral care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with black stains
- •Patients with high compliance
排除标准
- •Patients suffering from psychological, neurological or psychiatric disorders
- •Pregnant or breastfeeding women
- •Patients undergoing anti-cancer therapy
- •Patients with low compliance
结局指标
主要结局
Change in the extension of black stains (Gasparetto et al., 2003)
时间窗: Study begin, 2 and 6 months.
Scoring criteria: * 1: presence of pigmented dots or thin lines with incomplete coalescence parallel to gingival margin; * 2: continuous pigmented lines, which can be easily observed and limited to half of the cervical third of the tooth surface; * 3: presence of pigmented stains extending beyond half of the cervical third of the tooth surface
次要结局
- Change in DMFS (Decayed Missing Filled Surfaces) score(Study begin, 2 and 6 months.)
- Dietary habits(Study begin, 2 and 6 months.)
- Change in DMFT (Decayed Missing Filled Teeth) score(Study begin, 2 and 6 months.)
研究者
Andrea Scribante
Research Resident, Principal Investigator
University of Pavia