Clinical Efficacy of a Novel Titania Nanoparticle-Reinforced Bonding Agent in Reducing Post-Restorative Sensitivity: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-restorative sensitivity in composite resin restoration
研究概览
简要总结
Type of study: Randomized Clinical trial To compare post-restorative sensitivity between titania nanoparticle reinforced bonding agent and bonding agent without nanoparticles in posterior composite restorations.
Participants aged 18 years and above with Class-I and Class-II Carious lesions are allocated in two groups. Group A will undergo composite restoration with Nanoparticles incorporated in bonding agent. Group B will undergo restoration without nanoparticles in bonding agent.
详细描述
In this study Novel titania nanoparticle reinforced bonding agent will be evaluated for post-restorative sensitivity in composite restorations. Participants following the Inclusion criteria will be allocated in this study by Consecutive non-random sampling technique. Participants will be divided into two groups A and B. After rubber dam isolation, carious lesion will be excavated. In group A, titania nanoparticle reinforced bonding agent will be used for restorative treatment while in group B, Bonding agent without nanoparticles will be used. Post-restorative sensitivity record will be taken at 24 hours, after one week and after one month. Sensitivity will be assessed using Visual analog scale (VAS) mean score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
This is a triple-blinded study in which the participant, care provider and outcome assessor will be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with good general health
- •Selected teeth should be vital and periodontally healthy
- •Class-I and II with minimal cavity depth of 3mm, not exceeding 5mm
- •Defective previous restorations in need of replacement (secondary caries/fractures)
- •Selected teeth should be in occlusion with natural or prosthetic antagonist and adjacent teeth
排除标准
- •Patients with Temporomandibular disorders
- •Extremely poor oral hygiene status
- •Teeth with very deep carious lesions
- •Teeth with periapical or periodontal pathology
- •Patients taking anti-inflammatory, analgesics or psychotropic drugs
- •History of spontaneous pain
- •Previously root canal treated teeth
结局指标
主要结局
Post-restorative sensitivity in composite resin restoration
时间窗: 1 month
Evaluation of bonding agent with titania nanoparticles and without nanoparticles on post-restorative sensitivity using Visual analog scale with scoring from 0 to 10. Score 10 means worst outcomes
次要结局
未报告次要终点
研究者
NEHAL AMIR
Principal Investigator
Pakistan Institute of Medical Sciences