A Prospective, Open-Label, Single-Arm Clinical Study to Evaluate the Effectiveness of a Restosmile Dental Care on Adult Participants with Dentinal Hypersensitivity.

Aurora Nutraceuticals Private Limited1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2025年8月4日最近更新: 2025年7月23日

试验速览

阶段: Unknown
状态: 进行中（未招募）
发起方
入组人数: 50
试验地点: 1
主要终点: 1.Change in dentinal hypersensitivity from baseline using objective and

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is Prospective, Open-Label, Single-Arm Clinical Study to Evaluate the Effectiveness of a Restosmile Dental Care on Adult Participants with Dentinal Hypersensitivity over 2 week period. A total 50 (both male & female participants) 18 to 70 years will be enrolled. The primary objective is to assess the change in dentinal hypersensitivity from baseline using objective and subjective assessments ( Thermal Test, Tactile Test, Visual Analogue Scale). Secondary objective is to assess change in oral health related quality of life using the dentine hypersensitive experience questionnaire, Monitoring the overall subjective sensitivity of entire dentition. The study includes 3 visits baselines, day 07, day 14 only.

研究设计

研究类型: Interventional
分配方式: Na
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•1.Males and non pregnant or non lactating females between 18 and 70 years of age.
•2.Participants with a self reported history of dentinal hypersensitivity.
•3.Presence of localized or generalized dentinal hypersensitivity.
•4.At least one or two teeth exhibiting sensitivity in response to stimuli.
•5.Demonstrate sensitivity to evaporative air stimulus (e.g., Schiff sensitivity score more than or equal to 2).
•6.Good general and oral health, with a minimum number of natural teeth (e.g., 20).
•7.Willing and able to participate in the study, follow the protocol, and provide signed informed consent.

排除标准

•Presence of conditions causing pain similar to DH, such as active dental caries, heavily restored or fractured teeth, pulpitis, or extensive loss of periodontal attachment/alveolar bone.
•Participants with orthodontic or prosthetic appliances that interfere with evaluation.
•Participants who have used desensitizing treatments (including toothpastes or mouthwashes) or received professional desensitizing procedures within a specified periodprior to baseline (e.g., two weeks to six months).
•Participants who have undergone vital teeth bleaching within a specified period prior to screening (e.g., two weeks).
•Participants taking medication that could affect pain perception (e.g., daily analgesics, anti-inflammatory drugs) or antibiotics within a specified period.
•Participants with a known history of hypersensitivity or allergy to ingredients in the restosmile dental care toothpaste.
•Participants who consume tobacco or alcohol.
•Suspected inability or unwillingness to comply with study procedures.
•Presence of oral processes or habits that keep dentinal tubules exposed, such as poor plaque control, enamel wear, cervical erosion, or incorrect oral hygiene technique.
•Diagnosis of specific diseases that cause gingival loss, such as necrotizing ulcerative gingivitis (NUG), periodontitis, or herpetic gingivostomatitis.
•Recent crown preparation that may expose dentinal tubules.