Reduction of Dentin Hypersensitivity and Enamel Demineralization in Patients With Celiac Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in dentin hypersensitivity assessed by Schiff Air Index
研究概览
简要总结
This single-center, randomized controlled clinical trial aims to evaluate the effectiveness of a home-based treatment using hydroxyapatite-based oral care products in adult patients with celiac disease who exhibit enamel demineralization and dentin hypersensitivity. Forty patients will be enrolled and randomly allocated into two parallel groups. The control group will perform home oral hygiene using only a hydroxyapatite-based toothpaste (Biorepair® Total Protection) twice daily. The trial group will follow the same regimen with the toothpaste, but will also apply a hydroxyapatite mousse (Biorepair® Plus Intensive Enamel Repair) once every evening before bedtime throughout the study period.
The primary objective is to assess the reduction in dentin hypersensitivity using the Schiff Air Index. Secondary outcomes include changes in plaque accumulation (Plaque Index), gingival bleeding (Bleeding on Probing), pain perception (Visual Analogue Scale), and caries experience (DMFT and DMFS indices). Enamel demineralization will be analyzed through near-infrared transillumination (DIAGNOcam), laser fluorescence (DIAGNOdent), and digital image analysis (ImageJ software).
All clinical parameters will be evaluated at baseline and after 1 week, 1 month, 3 months, and 6 months. The study seeks to determine whether the addition of a remineralizing mousse to daily oral care provides superior benefits in reducing sensitivity and improving enamel integrity in patients with celiac disease.
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
- None
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
- •Adults (≥18 years of age) with a confirmed diagnosis of celiac disease.
- •Presence of enamel defects (hypomineralization or demineralization).
- •Presence of active carious lesions.
- •Self-reported dentin hypersensitivity.
- •Willingness to comply with the study protocol and follow-up schedule.
- •Written informed consent provided.
排除标准
- •Age below 18 years.
- •Absence of confirmed celiac disease.
- •Poor compliance or low motivation to participate in a 6-month study.
- •Ongoing treatment with products affecting enamel mineralization.
- •Pregnancy or breastfeeding.
- •Participation in another clinical trial within the previous 30 days.
研究组 & 干预措施
Biorepair Toothpaste + Mousse
Participants in this group will perform home oral hygiene using Biorepair® Total Protection toothpaste twice daily and apply Biorepair® Plus Intensive Enamel Repair mousse once every evening before bedtime for the duration of the study (6 months).
干预措施: Biorepair Toothpaste and Mousse (Device)
Biorepair Toothpaste Only
Participants in this group will perform home oral hygiene using Biorepair® Total Protection toothpaste twice daily, without the use of the additional mousse. This regimen will continue for the entire 6-month study period.
干预措施: Biorepair® Toothpaste (Device)
结局指标
主要结局
Change in dentin hypersensitivity assessed by Schiff Air Index
时间窗: Baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4)
The primary outcome is the variation in dentin hypersensitivity scores measured using the Schiff Air Index at baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4). The Schiff Air Index is a validated clinical scale ranging from 0 to 3, where higher scores indicate greater sensitivity. The primary analysis will compare the change in scores over time between the experimental group (toothpaste + mousse) and the control group (toothpaste only).
次要结局
- Change in plaque accumulation assessed by Plaque Index (PI)(Assessed at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) from the start of treatment.)
- Change in gingival bleeding assessed by Bleeding on Probing (BoP)(Evaluated at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after treatment initiation.)
- Change in self-reported pain using Visual Analogue Scale (VAS)(Measured at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) from the beginning of the intervention.)
- Change in caries experience using DMFT Index(Assessed at baseline (T0), and at follow-up visits at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4).)
- Change in caries experience using DMFS Index(Recorded at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after enrollment.)
- Change in enamel lesion area assessed by DIAGNOcam and ImageJ software(Evaluated at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) from treatment initiation.)
- Change in enamel fluorescence using DIAGNOdent(Obtained at baseline (T0), and at follow-up evaluations at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) following the start of treatment.)
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia