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临床试验/CTRI/2024/05/067196
CTRI/2024/05/067196尚未招募2/3 期

Comparative evaluation of Desensitizing effect of Aegle marmelos toothpaste, Spinacia oleracea toothpaste and their combination with commercially available desensitizing toothpaste: A Double-blinded Randomized Controlled Trial

Dr Yuvarani K P1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Assessment of dentin hypersensitivity using tactile stimulus and thermal stimulus test which includes air-blast, cold, and application of an acidic solution

研究概览

简要总结

The gold standard treatment modality for dentin hypersensitivity has not yet been established. There are two strategies to control the hydrodynamic mechanism of pain for managing DH. Agents that reduce fluid flow within the dentine tubules by occluding the tubules, thereby blocking the stimuli, and those that interrupt the neural response to the stimuli. Oxalates reduce dentinal hypersensitivity by occluding the dentinal tubules and Potassium reduces dentinal hypersensitivity by either occluding the dentinal tubules or desensitization of nerve fibers/blocking the neural transmission. Since Aegle marmelos and Spinacea oleracea contain more potassium with phenols and oxalates respectively, this study emphasizes the herbal desensitizing toothpaste containing Aegle marmelos (Bilwa/Bael) and Spinacea oleracea (Spinach) to reduce the dentin hypersensitivity in the age group of 20-50 years through tactile, thermal test using visual analog scale and schiffs score with the followup evaluation at 2nd and 4th week.

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, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients in the age group of 20–50 years 2)Patients with a minimum of two hypersensitive teeth which are anterior to molars and demonstrated signs of facial/cervical erosion, abrasion, and/or gingival recession.
  • The study teeth must be caries-free and with no restorations; 4)Patients who haven’t used any desensitizing toothpaste within the last 3 months 5)Patients with either no clinical mobility or grade I mobility will be included.
  • Patients who are willing to be available during the duration of the study and to sign an informed consent form.

排除标准

  • Patients with gross underlying pathologies.
  • Subjects with any other systemic/psychological conditions.
  • Pregnant and lactating females will be excluded 4)Development alterations like hypoplasia or fluorosis.
  • Use of orthodontic device or appliance 6)Subjects with any history of allergy reactions to herbal medicaments or toothpaste 7)Subjects suffering from a chronic medical disease or conditions which are associated with intermittent episodes or constant daily pain 8)Subjects who are taking certain medications (anti-inflammatory drugs or antibiotics) daily during the previous 7 days; 9)Subjects who are unwilling to complete the treatment protocol.

结局指标

主要结局

Assessment of dentin hypersensitivity using tactile stimulus and thermal stimulus test which includes air-blast, cold, and application of an acidic solution

时间窗: 2nd week and 4th week

次要结局

  • Visual analog scale and schiff score(2nd week and 4th week)

研究者

发起方
Dr Yuvarani K P
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Dr Yuvarani K P

KAHER’s KLE Vishwanath Katti Institute of Dental Sciences

研究点 (1)

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