NCT07628712

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
May 2026Sep 2027

First Submitted

Initial submission to the registry

April 24, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

May 18, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

June 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

April 24, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

dentine hypersensitivitybioactive glassresin bonding system

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, immediately, 1 month, 3 months and 6 months after intervention

Study Arms (2)

Control

ACTIVE COMPARATOR

A single application of a universal dentine adhesive

Other: Universal dentine adhesive

Intervention

EXPERIMENTAL

A single application of strontium-doped bioactive glass ceramic-filled dentine adhesive

Drug: Strontium-doped bioactive glass-ceramic-filled dentine adhesive

Interventions

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

Intervention

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

Control

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \) \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Katherine CM LEUNG, BDS MDS PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine CM LEUNG, BDS MDS PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

June 5, 2026

Study Start

May 18, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

June 5, 2026

Record last verified: 2026-03