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临床试验/NCT07628712
NCT07628712尚未招募不适用

Dentine Hypersensitivity Treatment Using Strontium-doped Bioactive Glass-ceramic-filled Dentine Adhesive: a Randomized Double-blind Controlled Clinical Trial

The University of Hong Kong0 个研究点目标入组 142 人开始时间: 2026年5月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
142

研究概览

简要总结

The goal of this clinical trial is to determine whether strontium-doped bioactive glass-ceramic (SBGC)-filled dentine adhesive is effective in relieving dentine hypersensitivity. The main question it aims to answer is:

Is SBGC-filled dentine adhesive more effective in reducing dentine hypersensitivity than non-SBGC-filled dentine adhesive?

Researchers will compare SBGC-filled dentine adhesive to a dentine adhesive to see if SBGC-filled dentine adhesive is more effective at relieving dentine hypersensitivity.

Participants will receive a single application of either SBGC-filled dentine adhesive (intervention group) or dentine adhesive (control group) on the root surfaces of teeth presenting with pain subject to an air-blast test. The degree of pain will be assessed using a Sensitivity Score at baseline, immediately after application of either the intervention dentine adhesive or control dentine adhesive. The participants will visit the clinic at 1 month, 3 months and 6 months for re-assessment of the severity of dentine hypersensitivity.

详细描述

Subjects aged 18-69 years who have experienced cervical dentine hypersensitivity for 1 month or more will be identified and recruited from those attending routine check-ups at a university teaching hospital, the Prince Philip Dental Hospital. Those who have poor dental conditions, such as severe periodontal conditions, or the sensitive tooth has undergone restorative treatment, or any other condition that potentially threatens the validity of the outcomes, will be excluded.

Each participant will undergo a baseline clinical examination to explore their level of oral hygiene, presence of dental caries and restorations, and their periodontal conditions. The participants will be asked to indicate the sensitive tooth/teeth, which will then be isolated and tested with a continuous air blast for 5 seconds using a 3-in-1 syringe. They will rate the degree of pain of the tooth under assessment using a Sensitivity Score that ranges from 0 to 10, where 0 indicates no discomfort and 10 indicates maximal pain causing significant distress.

Randomization will be conducted at the subject level in a 1:1 ratio. Subjects who have at least one hypersensitive tooth with an SS score of 8 or above will be randomly allocated to one of the two study groups.

Socio-demographic information regarding age and gender; education level; type of housing resided; number and types of medications; health/medical conditions; dietary habits; tobacco use; oral hygiene habits including toothbrushing habits; and dental visit behaviour will be recorded.

After the baseline clinical examination, participants in the intervention group will receive a single application of a bioactive glass ceramic-filled universal dentine adhesive, whereas those in the control group will receive a single application of the same universal dentine adhesive without bioactive glass ceramic. The study participants will be followed for 6 months. Assessment for dentine hypersensitivity will be conducted immediately after the intervention, at the 1-month, 3-month and 6-month follow-up visits using the same equipment and diagnostic criteria by the same examiner.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • individuals who experienced cervical dentine sensitivity for 1 month or more

排除标准

  • 1) <20 teeth; 2) teeth with poor oral hygiene, severe periodontal conditions, with caries, faulty restorations, dentine exposure at the occlusal surface, covered by prosthetics or orthodontic appliances, or undergoing endodontic treatment; 3) currently using or have used any desensitizing agents in the past 3 months; or have undergone restorative treatment on the sensitive tooth; 4) with a severe medical condition or in chronic use of a medication that could have interfered with the perception of pain or any condition/medication that causes xerostomia

研究者

申办方类型
Other
责任方
Sponsor

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