CTRI/2025/11/097706尚未招募3 期
A Randomized Clinical Study On Effectiveness Of Light Cured Ormocer Based Desensitizer And Diode Laser Alone Or In Combination For The Treatment Of Dentine Hypersensitivity
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in Dentine Hypersensitivity
研究概览
简要总结
This study is a randomised, Single blind, parallel group, multiple arm trial comparing the effectiveness of light cured ormocer based Desensitizer and Diode Laser when used alone or in combination in 15 patients comprising 60 samples at baseline, Immediately after treatment and after 4 weeks for reducing dentinal hypersensitivity which is a common problem among dental patients. The Primary outcome measures will be reduction in hypersensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects should be dentally mature in the age group of 19-60 years and have sensitive teeth with a clinical diagnosis satisfying the definition of dentin hypersensitivity.
- •2.Patient with at least one hypersensitive tooth following air blast and tactile at the screening and baseline visit with baseline VAS score more than 4, in each of the four quadrants.
- •3.Patient complaining of sensitivity due to mechanical, thermal or chemical stimuli.
- •4.Early non-carious lesions including those which do not require restorations.
- •5.Good oral hygiene.
- •6.No previous treatment for dentinal hypersensitivity.
- •7.Both males and females included.
- •8.Readiness of the patient to sign the consent form.
排除标准
- •1.Medical and pharmacotherapeutic histories that may compromise the protocol including the chronic use of anti-inflammatory, analgesic and psychedelic drugs.
- •2.Benign or malignant pathological oral lesions.
- •3.Caries in the selected or adjacent teeth.
- •4.Teeth with non-carious lesions with pulpal involvement.
- •5.Congenital enamel or dentin defects.
- •6.Crazed or hypoplastic teeth.
- •7.Pregnancy or breast feeding.
- •8.Allergies and idiosyncratic responses to product ingredients.
- •9.Systemic conditions that are etiological or predisposing to dentin hypersensitivity.
- •(e.g chronic acid regurgitation) 10.Excessive dietary or environmental exposure to acids and Eating disorders.
- •11.Teeth or supporting structures with any other painful pathology or defects.
- •12.Teeth restored in the preceding 5 months.
结局指标
主要结局
Reduction in Dentine Hypersensitivity
时间窗: 1. Baseline | 2. Immidiately after treatment | 3. 4 Weeks after treatment
次要结局
未报告次要终点
研究者
Dr Pradnya Nagmode
SMBT Dental College and Hospital Sangamner
研究点 (1)
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