Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cold pulp testing
研究概览
简要总结
this clinical study will be carried out to evaluate the effect of fluoride varnish with silver nanoparticles in comparison to silver diamine fluoride in management of deep carious lesions.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •success will be evaluated by:
- •Cold pulp testing: An ice-rod will be used for this test. Results should be positive or negative.
- •Absence of spontaneous pain: Post-operative pain will be assessed using the visual Analogue Scale Score (VAS), which is a measurement method for subjective characteristics of pain. Respondents specify their level of agreement to a statement by indicating a position along a 10 cm line between two end-points, with the term "no sensitivity" at one end and "intolerable sensitivity" at the other end. A score from (0 to 10 is given).
- •Sensitivity to percussion: (presence/ absence).
- •Inspection for Sinus/fistula/swelling: using visual inspection (presence/ absence).
- •Radiographic examination: Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence).
排除标准
- •Patient-related criteria:
- •Medically compromised patients, who will not be able to attend multiple appointments or may require special management.
- •Pregnant women; as radiographs cannot be taken for them.
- •Allergy to any of the restorative materials, including anesthetics.
- •Uncooperative patients, will not abide by the instructions or attend the appointments.
- •Tooth related criteria:
- •Retained deciduous teeth; as the study is targeting only permanent teeth.
- •Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries.
- •Teeth with cervical caries; which can't be evaluated on periapical radiographs
研究组 & 干预措施
silver nanoparticles
干预措施: silvernanoparticles (Drug)
silverdiamine fluoride
干预措施: SDF (Drug)
结局指标
主要结局
Cold pulp testing
时间窗: 6 months
: An ice-rod will be used for this test. Results should be positive or negative.
Absence of spontaneous pain
时间窗: 6 month
Post-operative pain will be assessed using the visual Analogue Scale Score (VAS), which is a measurement method for subjective characteristics of pain. Respondents specify their level of agreement to a statement by indicating a position along a 10 cm line between two end-points, with the term "no sensitivity" at one end and "intolerable sensitivity" at the other end. A score from (0 to 10 is given).
Radiographic examination
时间窗: 6 month
Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence).
sensitivity to percussion
时间窗: 6 month
recorded as yes or no
visual inspection for sinus/ fistula swelling
时间窗: 6 month
recorded as yes or no
次要结局
未报告次要终点
研究者
Kareem Hamdy Ahmed Aly
principal investigator
Suez Canal University