Effectiveness of Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Radiographic evaluation of reparative dentin formation
研究概览
简要总结
The aim of this study is to evaluate and compare the clinical effectiveness of 38% silver diamine fluoride with and without potassium iodide with that of resin modified glass ionomer cement in indirect pulp capping of young permanent molars.
详细描述
A sample of children with an age range of 6-9 years, having a first permanent molar erupted with deep occlusal carious lesion, will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. All selected 108 first permanent molars will be randomly equally allocated into three groups according to capping material used. Group I (n=36) SDF/ KI and Group II (n=36) SDF and Group III (n=36) Glass ionomer cement. Indirect pulp capping treatment procedure will be performed with identical protocols except for the capping material to be used and its application will be according to manufacturer's instructions. Glass ionomer cement will be used as a base and resin-based composite restoration will be used in the three groups.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For children:
- •Children who are generally healthy.
- •Children having a deep dentin carious lesion in a permanent first molar (upper or lower).
- •Parents signed informed consent.
- •For first permanent molars:
- •Cavitated class I carious lesions with opaque or discolored enamel exposing the dentin beneath corresponding to ICDAS II score 5 and 6 (visible dentin). (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007)
- •Teeth having lesions that are considered active according to ICDAS II activity criteria for primary coronal caries. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)
- •Immature with open apex as revealed by periapical X-ray.
排除标准
- •For children:
- •Any allergy reported by the parents. (Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, et al. 2017)
- •Children unable to return for recall visits.
- •For first permanent molars:
- •Any clinical signs of irreversible pulpitis (spontaneous pain, pain on percussion, abscess, sinus.
- •Any radiographic sign of irreversible pulp pathologies or necrosis periapical radiolucency, internal or external root resorption).
- •Teeth with inactive lesions. (Ekstrand KR, Martignon S, Ricketts D, Qvist V. 2007; Dikmen B. 2015)
研究组 & 干预措施
Silver diamine fluoride/ potassium iodide group
Riva Star Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia
干预措施: Silver diamine fluoride/ potassium iodide (Drug)
Silver diamine fluoride group
Advantage arrest TM, Elevate Oral Care, USA
干预措施: Silver diamine fluoride (Drug)
Resin modified glass ionomer cement group
Riva light cure, SDI, Bayswater, Australia
干预措施: Resin modified glass ionomer cement (Drug)
结局指标
主要结局
Radiographic evaluation of reparative dentin formation
时间窗: 12 months
Reparative dentin formation, if present, will be measured in millimetre on standardized digital radiographs taken by parallel technique (digora software). (Menon NP, Varma BR, Janardhanan S, Kumaran P, Xavier AM, 2016)
Success of the restoration
时间窗: 12 months
Clinical success of the whole restoration will be ranked according to Modified Ryge/USPHS Clinical Criteria (Colour, marginal adaptability, marginal staining, and secondary caries). (Moncada G, Silva F, Angel P, Oliveira Jr O, Fresno MC, Cisternas P, et al. 2014)
Postoperative pain
时间窗: 12 months
Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no). (American Academy of Pediatric Dentistry. 2019)
Tooth Vitality
时间窗: 12 months
Tooth vitality will be assessed by vitality test using thermal stimulation, binary (yes or no). (American Academy of Pediatric Dentistry. 2019)
Radiographic evaluation or root lengthening
时间窗: 12 months
Root lengthening will be assessed by measuring the root length in mm from cement-enamel junction on standardized digital radiographs taken by parallel technique (digora software). (Flake NM, Gibbs JL, Khan AA. 2014)
Radiographic evaluation of reparative dentin volume
时间窗: 12 months
This was measured using cone beam computed Tomography (CBCT). Reparative dentin radiodensity will be measured in Hounsfield units (HU). (Mathur VP, Dhillon JK, Logani A, Kalra G. 2016)
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Dental Public Health clinical instructor and study statistician
University of Alexandria