Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Tactile exam to evaluate extend of caries around tooth margin
研究概览
简要总结
Dental caries is a multifactorial, progressive disease which is the major causes of dental pain, infection and tooth loss. Dental caries can substantially compromise the quality of life in older adults 1 2. As the number of older adults in the US increases, the dental professionals have become increasingly concerned with the dental need of elderly and preventive regimes to reduce the incidence of caries3 .
Prevention becomes an area of paramount importance. Many studies have advocated nonsurgical intervention for shallow dentin caries lesion.The most effective method for prevention to date is considered to be fluoride. In the United states fluoride has been incorporated in many ways like water fluoridation, fluoride mouth wash, dentifrices and professionally applied fluoride varnishes . The American Dental Association (ADA) recommended the use of fluoride for patients of all ages who are at risk of developing dental caries7 . With the high success of fluoride, another treatment method using Silver Diamine Fluoride (SDF) is gaining popularity in the United States. SDF has been used in many countries like Japan, Australia, China, and Cuba for treatment of caries . Successful treatment data from other countries is promising, and promoting the use of SDF in the United States. SDF is available in the United States as 38% aqueous solution and approved as a desensitizing agent. American Dental Association published an evidence-based clinical practice guideline on nonrestorative treatments for caries teeth and recommended use of SDF on a carious cavitated lesion on permanent teeth9 . Clinical studies have shown the effectiveness of SDF in arresting root caries in older adults.
详细描述
Potential subjects will be identified through regular appointments. Screening will be performed on subjects to determine their eligibility based on inclusion and exclusion criteria. Subjects will sign an informed consent before enrollment in the study. Patient will be receiving one of the two fluoride treatments, Silver Diamine Fluoride or Sodium fluoride, to arrest caries around crown margins. Clinical and radiographic exam will be performed on all the participants.
Clinical exam will include the following
- DIAGOdent:
- Tectile exam:
The procedures of every clinical appointments will be as following:
First appointment:
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
- Double (Participant, Investigator)
盲法说明
Participants will not know which type of fluoride they are getting around their crow margins.
Principal investigator will measuring the extend of the decay does not know about the type of fluoride treatment patient got.
入排标准
- 年龄范围
- 65 Years 至 85 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65-85 years old with crown/bridges
- •Open crown margins
- •Decay present around crown margins
- •Pt is not intention to go with the conventiontial restorative treatment to replace the crown for any reason
- •Subjects who can do the follow up for at least one year
排除标准
- •Teeth with periapical lesion
- •Teeth which have pain to percussion
- •Subjects who have silver or fluoride allergy
- •Subjects who have gingivitis
- •Subjects who have stomatitis
- •Subjects who have tooth mobility
- •Subjects who have furcation involvement
研究组 & 干预措施
Intervention group
Subjects in this group will receive Silver Diamine Fluoride around their crown margins every six month for the next 3 years.
干预措施: Silver Diammine Fluoride (Drug)
Fluoride varnish group
Subjects in this group will receive fluoride varnish around their crown margins every six month for the next 3 years.
干预措施: Fluoride Varnishes (Drug)
结局指标
主要结局
Tactile exam to evaluate extend of caries around tooth margin
时间窗: Every 6 month for next 3 years
WHO ball end probe will be used to detect cavities around the restoration margins. Code 0: Sound tooth surface with restoration Code 1: First visual change in enamel Code 2: Distinct visual change in enamel/ dentin adjacent to restoration Code 3: Carious defect of more than 0.5 mm Code 4: Marginal caries in enamel/dentin/cementum adjacent to restoration with dark shadow Code 5: Distinct cavity adjacent to restoration Code 6: Extensive distinct cavity with visible dentine
次要结局
- DIAGOdent: laser fluorescence to aid in the detection of caries(Every 6 month for next 3 years)
研究者
Shaista Rashid
Assistant Clinical Professor
University of New England
