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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-69
SponsorThe University of Hong Kong

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

individuals who experienced cervical dentine sensitivity for 1 month or more

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    universal dentine adhesive (ScotchbondTM Universal Adhesive, Neuss, Germany)

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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