Clinical Efficacy of Novel Jasminum-based Nano-reinforced Calcium Hydroxide Medicament on Postoperative Pain: a Triple-blind Study
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-operative pain
研究概览
简要总结
A triple-blind, parallel group, randomized trial with an allocation ratio of 1:1. Participants randomly allocated into two groups A and B. In group A, nano-reinforced calcium hydroxide medicament was utilized while in group B, calcium hydroxide medicament without nanoparticles was used. Post-operative pain was assessed after 4 hours, 24 hours, 48 hours, 72 hours, 96 hours.
详细描述
This triple-blind parallel group, randomized clinical trial was conducted at the department of Operative Dentistry and Endodontics, School of Dentistry from April 24, 2024 to September 25, 2024. Participants were randomly distributed into two groups by Lottery method. A consecutive non-probability sampling technique was used. Before initiating treatment, participants were briefed about the intervention and their preoperative pain score was recorded. In both groups, endodontic treatment was initiated under rubber dam isolation. Access opening done and canals explored. Working length taken by radiographic method and reconfirmed by an electronic apex locator. Afterwards, canals were prepared till Master Apical File size F2 (4% Taper). In group A, Nano-reinforced calcium hydroxide medicament was placed while in group B, calcium hydroxide without nanoparticles was utilized. Participants were instructed to rate their postoperative pain record after 4hrs, 24hrs, 48hrs, 72hrs and 96hrs.
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
In this triple-blind trial, participants, care provider and outcome assessor were unaware of the study groups.
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
- •Participants with good general health status
- •Necrotic pulp with Symptomatic Apical Periodontitis
- •Single rooted teeth
排除标准
- •Non-restorable teeth
- •Teeth associated with acute or chronic apical abscess
- •Teeth with chronic periodontitis
- •Teeth with anatomical complexities or complications like open apex, calcified canal, severe root dilaceration, root resorptive defects
- •Participants who received antibiotic treatment during the last 3 months
- •Pregnant females
- •Participants on pre-treatment analgesics
研究组 & 干预措施
Group A (Nano-reinforced Calcium hydroxide)
Nano-reinforced Calcium hydroxide Medicament
干预措施: Nano-reinforced calcium hydroxide medicament (Drug)
Group B (Conventional Calcium hydroxide)
Calcium hydroxide without nanoparticles
干预措施: Calcium hydroxide without nanoparicles (Drug)
结局指标
主要结局
Post-operative pain
时间窗: One week
Pain scores assessed by Visual Analogue Scale (VAS) score after 4hr, 24hrs, 48hrs, 72hrs, 96hrs. The minimum score is O (None) and the maximum score is 10 (Severe).
次要结局
未报告次要终点
研究者
NEHAL AMIR
Principal Investigator
Pakistan Institute of Medical Sciences