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临床试验/NCT07102121
NCT07102121Enrolling By Invitation不适用

Comparison of Post Cementation Sensitivity Between Resin-Modified Glass Ionomer Cement and Conventional Glass Ionomer Cement as a Luting Material: A Randomized Clinical Trial

Saidu College of Dentistry2 个研究点 分布在 1 个国家目标入组 496 人开始时间: 2025年1月25日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
496
试验地点
2
主要终点
Dentinal sensitivity

研究概览

简要总结

This randomized controlled trial aims to compare post-cementation sensitivity between resin-modified glass ionomer cement (RMGIC) and conventional glass ionomer cement (GIC) as luting materials. Conducted at the Prosthodontics Department, Saidu College of Dentistry, Swat, the study will enroll 248 patients aged 15-70 with vital abutment teeth, randomly assigned to receive either RMGIC or GIC. Sensitivity will be assessed using a 10-point Visual Analog Scale (VAS), with scores above 1 considered indicative of post-operative sensitivity and further categorized for analysis. Strict inclusion/exclusion criteria and randomization will control bias and confounders. Data will be analyzed in SPSS 22 using t-tests and chi-square tests, with significance set at p≤0.05.

详细描述

Dental prostheses are frequently used to replace missing teeth. Fixed partial dentures are regarded as the gold standard for restoring lost teeth, aiming to recover proper function, speech, and appearance. These fixed prostheses must be securely attached to the neighboring teeth using specific bonding agents known as luting cements. Ideal luting materials should exhibit low solubility, biocompatibility, resistance to leakage, and should not cause discomfort or sensitivity after cementation. Common luting agents include glass ionomer cement (GIC), resin-modified glass ionomer cement (RMGIC), zinc phosphate cement, and zinc oxide eugenol cement. Among these, GIC and RMGIC are considered reliable and long-lasting choices for luting purposes.

This randomized controlled trial aims to compare post-cementation sensitivity between resin-modified glass ionomer cement (RMGIC) and conventional glass ionomer cement (GIC) as luting materials. Conducted at the Prosthodontics Department, Saidu College of Dentistry, Swat, the study will enroll 248 patients aged 15-70 with vital abutment teeth, randomly assigned to receive either RMGIC or GIC. Sensitivity will be assessed using a 10-point Visual Analog Scale (VAS), with scores above 1 considered indicative of post-operative sensitivity and further categorized for analysis. Strict inclusion/exclusion criteria and randomization will control bias and confounders. Data will be analyzed in SPSS 22 using t-tests and chi-square tests, with significance set at p≤0.05.

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

In this study, masking will be applied to the participants and the outcomes assessor to reduce performance and detection bias. Participants will not be informed about the type of luting cement used during their treatment. The outcomes assessor, responsible for evaluating post-cementation sensitivity, will also be blinded to group allocation to ensure unbiased data collection. However, due to the clinical differences in handling the materials, the care providers and investigators cannot be masked.

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 15 to 70 years
  • Both male and female participants
  • Abutment teeth with vital pulp
  • Sound abutment teeth with no signs of attrition, erosion, or abrasion
  • No history of pulp capping procedures on abutment teeth

排除标准

  • Patients currently undergoing orthodontic treatment or who completed it within the last 3 months
  • Use of bleaching or desensitizing agents
  • History of recent periodontal surgery
  • Patients on medications that affect pain perception (e.g., analgesics, carbamazepine)
  • Patients with psychiatric conditions that may affect pain reporting or compliance

结局指标

主要结局

Dentinal sensitivity

时间窗: At 24 hours, one week, one month, 2 months and three months after cementation

Patient-reported sensitivity will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain/sensitivity and 10 indicates the worst possible pain/sensitivity. A VAS score greater than 1 will be considered as post-cementation sensitivity. The scores will also be categorized as: No sensitivity: VAS 0-1 Mild: VAS 2-3 Moderate: VAS 4-7 Severe: VAS 8-10

次要结局

未报告次要终点

研究者

发起方
Saidu College of Dentistry
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Ajmal Khan

saiduCDentistry

Saidu College of Dentistry

研究点 (2)

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