Efficacy of Irimedadi oil compared to 8 percentage arginine toothpaste as a desensitizing agent - A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Dentinal Hypersensitivity
研究概览
简要总结
Dentinal hypersensitivity, caused by exposed dentinal tubules due to enamel or cementum wear, significantly affects patients’ daily lives by causing pain that disrupts sleep, work, and dietary habits. While self-applied desensitizing toothpastes like Colgate Sensitive Pro-relief, which contains 8% arginine, are commonly used, their primary disadvantage is the time needed for symptom relief. Irimedadi Oil, an Ayurvedic preparation with astringent, antimicrobial, and anti-inflammatory properties, is effective against various oral conditions, including dentinal hypersensitivity. A study reported that 26% of patients experienced relief after 10 days of using Irimedadi Oil, increasing to 76% after 21 days. If found effective, Irimedadi oil would be a natural, organic, herbal alternative for hypersensitivity patients.
A Randomized controlled trial will be conducted to evaluate the effectiveness of Irimedadi Oil against Colgate Sensitive Pro-relief in patients with dental hypersensitivity. Patients from a dental outpatient department will be selected based on specific inclusion and exclusion criteria. A pilot study with 25 patients in both groups will be conducted for 10 days. This will help determine the sample size for a 21-day trial.
In the study, 50 subjects will be randomly divided into two groups using by block randomization method, with one group receiving Irimedadi Oil and the other Colgate Sensitive Pro-relief.
A Double-blinded methodology will be followed in which the investigator and the analyzer will be blinded as the agents will be distributed in prenumbered concealed containers.
Baseline tactile, air blast, and cold sensitivity assessments will be conducted using established pain and sensitivity scales. Participants will follow specific application instructions for the oil or toothpaste and be asked to use non-fluoridated toothpaste for regular brushing. Follow-ups will be scheduled after 10 and 21 days to reassess sensitivity using the same tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Subjects presenting complaints of dentinal hypersensitivity which may be due to attrition, erosion, gingival recession, and root exposure or unrestorable cervical abrasion lesions.
- •b) Subjects who are 18 years and above.
- •c) Subjects having a minimum of one tooth with dentinal hypersensitivity.
排除标准
- •a) Subjects not willing to participate.
- •b) Subjects with complaints of sensitivity due to caries, deep abrasions requiring class V restorations, chipped teeth, and fractured cusps.
- •c) Subjects using any type of desensitizing therapy from the last 6 months.
- •d) Subjects with a history of chronic use of analgesics or anti-inflammatory drugs, pregnant or lactating females, and those with any denture or bridgework that would interfere in the evaluation of hypersensitivity.
- •e) Subjects who use any dental aids other than toothbrushes and toothpaste to clean their teeth.
- •f) Subjects with dentinal hypersensitivity in which restorations can be suggested as a treatment plan.
结局指标
主要结局
Dentinal Hypersensitivity
时间窗: Baseline | 10 days | 21 days
次要结局
- Reduction in gingivitis(Follow up at 10 days & 21 days)
研究者
Dr Jishnu Pradeep
Manipal College of Dental Sciences, Manipal