Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Katherine CM LEUNG, BDS MDS PhD
- Telefoonnummer: 852-28590307
- E-mail: kcmleung@hku.hk
Studie Contact Back-up
- Naam: Minnie Y He, BDS MDS PhD
- Telefoonnummer: 852-28590307
- E-mail: u3012606@connect.hku.hk
Studie Locaties
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Hong Kong, Hongkong
- Werving
- Clinical Research Center, the Prince Philips Dental Hospital
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Contact:
- Catherine Mok
- Telefoonnummer: 28590222
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Hong Kong, Hongkong
- Werving
- the University of Hong Kong
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Contact:
- Katherine Chiu Man Leung, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Control
A single application of a universal dentine adhesive |
universal dentine adhesive (ScotchbondTM Universal Adhesive, Neuss, Germany) |
|
Experimenteel: Intervention
A single application of 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Severity of dentine hypersensitivity measured by a sensitivity score
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Katherine CM LEUNG, BDS MDS PhD, The University of Hong Kong
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UW25-491
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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