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NCT Number: NCT07628712

Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic

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.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Strontium-doped bioactive glass-ceramic-filled dentine adhesive

Drug

Strontium-doped bioactive glass-ceramic-filled dentine adhesive

Strontium-dope bioactive glass-ceramic: Dencare (Chongqing) Oral Care Company Limited

Dentine adhesive: ScotchbondTM Universal Adhesive, 3M ESPE, Deutschland GmbH, Neuss, Germany

Universal dentine adhesive

Other

universal dentine adhesive (ScotchbondTM Universal Adhesive, 3M ESPE, Deutschland GmbH, Neuss, Germany)

Primary outcomes

  1. Severity of dentine hypersensitivity measured by a sensitivity score

    Time frame: Baseline, immediately, 1 month, 3 months and 6 months after intervention

    The tooth/teeth with dentine hypersensitivity will be identified. A 3-in-1 air syringe will be used to provide a continuous air blast for 5 seconds. The participants will rate the degree of pain of all the teeth under assessment using a Sensitivity Score (SS) which is a visual analog scale modified with the addition of adjective words and facial expression diagrams according to the verbal descriptor scale. The SS ranges from 0 to 10, where 0 indicates no discomfort and 10 indicates maximal pain causing significant distress.

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine CM LEUNG, BDS MDS PhD

CONTACT

[email protected]

852-28590307

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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