Efficacy of Gluma Desensitizer in Controlling the Immediate Post-treatment Sensitivity in Etch-and-rinse and Self-etch Adhesive Bonded Occlusal Composite Restorations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 570
- 试验地点
- 2
- 主要终点
- Number of Participants With Post-operative Sensitivity Having VAS Score >3
研究概览
简要总结
To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.
详细描述
The primary objective of this study is to observe the effect of gluma desensitizer application in controlling the post-treatment sensitivity in posterior occlusal composite restoration in molar teeth using 2 adhesive bonding strategies.
The secondary objective is to evaluate the difference in the post-treatment sensitivity on application of Gluma desensitizer either prior to or after acid etching.
The different adhesive gluma desensitizer application groups are randomly divided into 6 groups,
- Total etch control group (No gluma desensitizer application)
- Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
- Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching
- Self etch control group (No gluma desensitizer application)
- Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
- Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching
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
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Occlusal cavitated caries in maxillary and mandibular first and second molars
排除标准
- •Occlusal caries with axial or proximal extension
- •Teeth with periodontal treatment within last three months
- •Teeth with cracks
- •Teeth to be taken as abutment for prosthesis
- •Patients with psychiatric treatment
- •Patients in orthodontic treatment or going to need orthodontic treatment
- •Patients under dentin hypersensitivity or using desensitizer treatment
- •Patients not willing for post treatment follow up
- •Patients having any other teeth with pain or sensitivity symptoms
- •Caries excavation with pulp exposure and post treatment sensitivity due to occusal interference in restoration
结局指标
主要结局
Number of Participants With Post-operative Sensitivity Having VAS Score >3
时间窗: 1 week
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) and cold spray VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
次要结局
- Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3(1 week)
研究者
Dr. Geeth Deepika
Principal Investigator
Tamil Nadu Dr.M.G.R.Medical University