Management of Dental Erosion in Patients With Gastroesophageal Reflux Disease With Biomimetic Hydroxyapatite Toothpaste
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of BEWE (Basic Erosive Wear Examination)
研究概览
简要总结
The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD).
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day
- Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3, 6, 9 and 12 months from baseline.
详细描述
The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD).
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day
- Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3, 6, 9 and 12 months from baseline.
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 with dental erosion
- •no proton pumps before pH examination
排除标准
- •no dental erosion
- •neurological and psychiatric diseases;
- •pregnant and/or breastfeeding women;
- •patients with poor compliance.
结局指标
主要结局
Change of BEWE (Basic Erosive Wear Examination)
时间窗: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Scoring criteria (Barlet et al., 2008): * 0: no erosive tooth wear; * 1: initial loss of surface texture; * 2: distinct defect, hard tissue loss \< 50% of the surface area; * 3: hard tissue loss ≥ 50% of the surface area. IntactTooth smartphone application will be used to calculate this index.
Change in Schiff Air Index - Dental sensitivity test
时间窗: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Scoring criteria: 0: the subject did not respond to air blasting; 1. the subject responded to air blasting; 2. the subject responded to air blasting and requested discontinuation; 3. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
Change in Plaque Index (PI% - O' Leary Index)
时间窗: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100
Change in Bleeding Score (BS - Mombelli et al.)
时间窗: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Scoring criteria: 0: no bleeding 1. isolated visible spots 2. blood forms a confluent red line on the mucosal margin 3. profuse and copious bleeding
Laryngopharyngeal pH monitoring
时间窗: Study begin, 1, 3, 6, 9 and 12 months after the baseline
Data was collected wirelessly for 24 hours and then analysed. Length, severity and number of reflux episodes were calculated. The RYAN score was used to evaluate for laryngopharyngeal acid reflux and was calculated for both the upright and supine positions. A RYAN score \>9.4 in the upright position or \>6.8 in the supine position was considered positive. Patients with a positive RYAN score in either the upright or supine positions were considered positive for laryngopharyngeal acid reflux.
Erosion risk level
时间窗: Study begin, 1, 3, 6, 9 and 12 months after the baseline
For each sextant, the highest BEWE value will be chosen. A mean of all the sextant values will be performed to calculate erosion risk level. IntactTooth smartphone application will be used to calculate this index.
次要结局
未报告次要终点
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia