In Vivo Quantification of Dental Demineralisation Using Optical Coherence Tomography Before and After Double-blind, Randomised Treatment With Esomeprazole or Placebo of Patients With Dental Erosions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Dental erosions by OCT
研究概览
简要总结
Dental erosions in 30 male and female patients with proven abnormal gastrooesophageal reflux will be assessed clinically and using a novel optical coherence tomography (OCT) laser technique before and after double-blind randomization to antisecretory treatment with esomeprazole 20mg or placebo bid for 3 weeks.
The primary objective is to quantify tooth substance loss as well as changes in optical reflectance and scattering of dental hard tissues with and without acid inhibition.
Secondary objectives are:
To compare standardised visual scoring with OCT quantification of reflux damage at the different time points on different teeth.
To assess sex differences in OCT- quantified dental tissue loss.
详细描述
Dental erosions in 30 male and female patients with proven abnormal gastrooesophageal reflux will be assessed clinically and using a novel optical coherence tomography (OCT) laser technique before and after double-blind randomization to antisecretory treatment with esomeprazole 20mg or placebo bid for 3 weeks.
The primary objective is to quantify tooth substance loss as well as changes in optical reflectance and scattering of dental hard tissues with and without acid inhibition.
Secondary objectives are:
To compare standardised visual scoring with OCT quantification of reflux damage at the different time points on different teeth.
To assess sex differences in OCT- quantified dental tissue loss
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Dental erosions with Lussi score greater than 1, diagnosed by dentist
- •Provision of informed consent
- •Male or female aged 18 or above years
- •GORD defined by time with pH<4 greater than 3.5% during 24 hours demonstrated by 24h-hour pH-metry in the last 6 months before the start of the study
排除标准
- •Significant illness within 2 weeks of study begin as judged by investigator.
- •Established or suspected non-reflux causes for dental erosions.
- •Inadequate exclusion of other causes for dental erosions (diet, psychiatric, bruxism, salivary abnormalities, vomiting, etc).
- •Inability or unwillingness to give informed consent.
- •Inability to attend all study.
- •New dental treatment (including dental products) may not be begun from 2 weeks before study begin until the end of the study, except usual dental hygiene with usual toothpaste.
- •Allergy to or other contraindication for treatment with esomeprazole.
- •Use of proton pump inhibitors in 2 weeks or other acid inhibitory drugs in 3 days before study inclusion.
- •Substantial change or planned change in dietary pattern, esp. diets within 2 weeks of study start and for the duration of the entire study.
- •Change or planned change in normal medication or use of herbal, mineral, vitamin preparations within 2 weeks of study start and until the end of the study.
- •Congenital dental defects.
- •Ongoing pregnancy or breast-feeding.
研究组 & 干预措施
placebo
Placebo tablet twice daily
干预措施: Placebo (Drug)
esomeprazole
Esomeprazole 20mg twice daily
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Dental erosions by OCT
时间窗: 3 weeks
次要结局
- OCT parameters(3 weeks)