Efficacy of Two Hydroxyapatite-Based Toothpastes on Enamel Remineralization: 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 DIAGNOdent Pen values in enamel fissures and upper central incisors
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the efficacy of two commercially available toothpastes containing hydroxyapatite in the remineralization of early enamel lesions. The study compares Biorepair® Total Protection Plus, which contains biomimetic microRepair particles, with Bioniq® Repair, a conventional hydroxyapatite-based toothpaste.
Forty participants will be randomly assigned to either the trial group (Biorepair®) or the control group (Bioniq®), and both groups will receive quarterly professional dental cleanings and use the assigned toothpaste twice daily for 6 months.
The primary outcome is the change in enamel demineralization, assessed by DIAGNOdent Pen scores, in permanent molar fissures and upper central incisors. Secondary outcomes include enamel integrity assessed by DIAGNOcam imaging and ICDAS scores, as well as changes in dental sensitivity (Schiff Air Index), erosive wear (BEWE Index), plaque accumulation (Plaque Index), gingival inflammation (Bleeding Index), and extrinsic stains (Modified Lobene Stain Index). Patient satisfaction will also be evaluated at the end of the study using a self-administered questionnaire.
This study will help determine whether biomimetic hydroxyapatite offers superior benefits in maintaining enamel health compared to conventional formulations, supporting evidence-based preventive strategies in dental care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 6 and 18 years
- •Ability to understand and follow instructions in Italian or English
- •Signed written informed consent provided by the parent/legal guardian and assent from the minor
- •Good cooperation and adherence to clinical instructions
- •Fully erupted permanent first molars and upper central incisors in good general condition
- •DIAGNOdent Pen baseline values in the C1 (0-12) or C2 (13-24) range
排除标准
- •DIAGNOdent Pen values greater than 25
- •Ongoing systemic antibiotic therapy
- •Presence of sealants or composite restorations on first permanent molars or upper central incisors
- •Severe enamel alterations such as molar-incisor hypomineralization (MIH), fluorosis, or extensive white/brown spot lesions
- •Poor motivation or limited compliance with study procedures
研究组 & 干预措施
Biorepair Group
Participants receive professional oral hygiene sessions every 3 months and use Biorepair® Total Protection Plus toothpaste (biomimetic microRepair-based) twice daily for 6 months.
干预措施: Biorepair® Total Protection Plus Toothpaste (Drug)
Bioniq Group
Participants receive professional oral hygiene sessions every 3 months and use Bioniq® Repair toothpaste (conventional hydroxyapatite-based) twice daily for 6 months.
干预措施: Bioniq® Toothpaste (Drug)
结局指标
主要结局
Change in DIAGNOdent Pen values in enamel fissures and upper central incisors
时间窗: Baseline to 6 months (T0-T3)
o assess the remineralizing efficacy of biomimetic hydroxyapatite (Biorepair® Total Protection Plus) compared to conventional hydroxyapatite (Bioniq® Repair) by evaluating the reduction in DIAGNOdent Pen fluorescence values recorded in the occlusal fissures of permanent molars and on the surfaces of upper central incisors. Measurements will be taken at four timepoints (T0, T1, T2, T3) over a 6-month period. The DIAGNOdent Pen provides a numerical score (0-99) based on laser fluorescence, where higher values indicate increased enamel demineralization. Lower values after treatment reflect improved enamel health and remineralization.
次要结局
- Change in ICDAS Scores via DIAGNOcam Imaging(Baseline to 6 months (T0-T3))
- Change in Dentin Hypersensitivity Using Schiff Air Index(Baseline to 6 months (T0-T3))
- Change in Enamel Erosion Using BEWE Index(Baseline to 6 months (T0-T3))
- Change in Plaque Accumulation Using Plaque Index(Baseline to 6 months (T0-T3))
- Change in Gingival Inflammation Using Bleeding Index(Baseline to 6 months (T0-T3))
- Change in Extrinsic Staining Using Modified Lobene Stain Index(Baseline to 6 months (T0-T3))
- Patient Satisfaction via Self-Administered Questionnaire(At 6 months (T3 only))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia