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

June 2, 2026 updated by: The University of Hong Kong

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Katherine CM LEUNG, BDS MDS PhD
  • Phone Number: 852-28590307
  • Email: kcmleung@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
A single application of a universal dentine adhesive
Other: Universal dentine adhesive
universal dentine adhesive (ScotchbondTM Universal Adhesive, 3M ESPE, Deutschland GmbH, Neuss, Germany)
Experimental: Intervention
A single application of strontium-doped bioactive glass ceramic-filled dentine adhesive
Drug: Strontium-doped bioactive glass-ceramic-filled dentine adhesive

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, immediately, 1 month, 3 months and 6 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Katherine CM LEUNG, BDS MDS PhD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 18, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW25-491

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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