Dentine HypersensitivityNCT07628712
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
A study testing Strontium-doped bioactive glass-ceramic-filled dentine adhesive and Universal dentine adhesive in people with Dentine Hypersensitivity, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- Strontium-doped bioactive glass-ceramic-filled dentine adhesive and Universal dentine adhesive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesHong Kong
- Study dates
- 16 Jun 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals who experienced cervical dentine sensitivity for 1 month or more
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
Clinical Research Center, the Prince Philips Dental Hospital
Hong Kong
Catherine Mok, 28590222
- Recruiting
the University of Hong Kong
Hong Kong
Katherine Chiu Man Leung, PhD
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Dentine Hypersensitivity
- Being tested
- Strontium-doped bioactive glass-ceramic-filled dentine adhesive, Universal dentine adhesive
- Keywords
- dentine hypersensitivity, bioactive glass, resin bonding system
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strontium-doped bioactive glass-ceramic-filled dentine adhesiveDrug
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 adhesiveOther
universal dentine adhesive (ScotchbondTM Universal Adhesive, Neuss, Germany)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | A single application of a universal dentine adhesive Receives: Other: Universal dentine adhesive |
| Intervention | Experimental | A single application of strontium-doped bioactive glass ceramic-filled dentine adhesive Receives: Drug: Strontium-doped bioactive glass-ceramic-filled dentine adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of dentine hypersensitivity measured by a sensitivity score
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.
Measured: Baseline, immediately, 1 month, 3 months and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start16 Jun 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentine HypersensitivityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine CM LEUNG, BDS MDS PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628712
- Sponsor's protocol ID
- UW25-491
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentine Hypersensitivity Treatment Using Strontium-doped Bioactive Glass-ceramic-filled Dentine Adhesive: a Randomized Double-blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07628712
- Acronym / sponsor ID
- UW25-491
- Conditions
- Dentine Hypersensitivity
- Keywords
- dentine hypersensitivity, bioactive glass, resin bonding system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Universal dentine adhesiveA single application of a universal dentine adhesive |
| Intervention | Experimental | Drug: Strontium-doped bioactive glass-ceramic-filled dentine adhesiveA single application of strontium-doped bioactive glass ceramic-filled dentine adhesive |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- individuals who experienced cervical dentine sensitivity for 1 month or more
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strontium-doped bioactive glass-ceramic-filled dentine adhesiveStrontium-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 | Drug | Intervention |
| Universal dentine adhesiveuniversal dentine adhesive (ScotchbondTM Universal Adhesive, Neuss, Germany) | Other | Control |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine CM LEUNG, BDS MDS PhD principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strontium-doped bioactive glass-ceramic-filled dentine adhesive and Universal dentine adhesive in people with Dentine Hypersensitivity, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine CM LEUNG, BDS MDS PhD (852-28590307, kcmleung@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of dentine hypersensitivity measured by a sensitivity score (time frame: Baseline, immediately, 1 month, 3 months and 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.