Can SAP P11-4 Increase The Radiopacity of Incipient Interproximal Carious Lesions on a Radiograph in a Military Population
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Mean Relative Radiographic Density of Interproximal Carious Lesions
研究概览
简要总结
The primary objective of the protocol is to learn about how SAP P 11-4 (produced commercially as Curodont products) can be used in a military population to treat incipient dental caries, or developing cavities that are still structurally intact and not too deep and increase awareness of the improvement and availability of minimally invasive treatment options for cavities in a military population.
详细描述
Potential subjects who have at least one interproximal incipient lesion on bitewing radiograph that is E1 (halfway into enamel), E2 (more than halfway into enamel), or D1 (into the outer third of dentin) will be identified through referral from dental providers at the Schofield Barracks Dental Clinic (SBDC). Subjects must have non-cavitated lesions (verified clinically where possible or by the absence of a visible break in the enamel surface on the radiograph).
Patients will be contacted by the principal investigator (PI) after a referral is made from a referring dentist. The PI will schedule the subject's initial consent appointment.
The PI reviews the informed consent with the patient and gives patient the chance to ask questions.
Signed consent will be obtained and the subject will be provided a copy of the signed form.
At the baseline study visit, a baseline bitewing will first be taken. The sensor will be centered on the interproximal lesion(s) that is being treated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active Duty military
- •must have 1 or more incipient, non-cavitated, interproximal carious lesions (E1, E2, or D1 in radiographic depth)
- •must have time remaining on post for at least 4 months from the start of treatment/enrollment
排除标准
- •non-active duty military
- •interproximal carious lesions that are cavitated or D2-D3 in radiographic depth
- •tobacco, nicotine, and e-cigarette use
研究组 & 干预措施
Curodont Repair Fluoride Plus Treatment Group
Participants with non-cavitated interproximal carious lesions (E1, E2, or D1) receive a single topical application of Curodont Repair Fluoride Plus at baseline following standardized bitewing radiography and oral hygiene instruction.
干预措施: 0.05% Sodium Fluoride with Self-Assembling Peptides (Drug)
结局指标
主要结局
Change in Mean Relative Radiographic Density of Interproximal Carious Lesions
时间窗: From enrollment to the end of treatment at 3 months. Measurements will be recorded periodically at baseline, 1 week after treatment, 1 month after treatment, and 3 months after treatment.
Radiographic lesion density is evaluated using digital bitewing radiography and image processing software. Relative Density is calculated using the formula: Relative Density = (Mean Gray Value of the Lesion ROI) / (Mean Gray Value of Sound Enamel ROI). The Region of Interest (ROI) is standardized using a rectangular box avoiding sound enamel, the outer enamel border, and the DEJ, overlaid onto subsequent recall radiographs via anatomical landmark alignment. A value of 1.0 indicates lesion density equal to healthy sound enamel, whereas values \< 1.0 indicate lower mineral density. Changes from baseline will be evaluated to assess remineralization and lesion arrest.
次要结局
未报告次要终点