A Phase 2 interventional study of SDF and KNO3 in Dentine Hypersensitivity, sponsored by The University of Hong Kong. Recruiting at 1 site in China. Open to participants aged 65 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by The University of Hong Kong · Phase 2, Interventional, and Treatment
Background: Dentine hypersensitivity is a common oral complaint from older adults. It induces pain, affects oral hygiene practice, limits food choices and negatively affects the quality of life. Silver diamine fluoride (SDF) is a desensitizing agent but well-designed clinical trials are lacking. The objective of this study is to evaluate the effectiveness of SDF in reducing dentine hypersensitivity in older Chinese adults.
Methods: This is a double-blinded randomised clinical trial recruiting 166 healthy older adults aged 65 or over after having written consent. A trained calibrated examiner will conduct clinical examination and assess dentine hypersensitive using a blast of compressed air delivered from 3-in-1 syringe. Older adults with a tooth with a self-perceived sensitivity score (SS) of 8 or above will be recruited. They will then be block randomised to receive either 38% SDF solution or 5% potassium nitrate every 4 weeks on the exposed root surface of the most hypersensitive tooth. The visible plaque index, bleeding on probing and probing depth (mm) will be recorded on the most hypersensitive tooth. The same examiner will perform clinical examination and assess the dentine hypersensitivity using the same tools and methods at 4-week and 8-week follow-ups. The examiner and older adults will be blinded to treatment allocation. The primary outcome is the percentage of change in SS before and after intervention at 8 weeks. The secondary outcome will be the percentage of change in VPI before and after intervention at 8 weeks.
Clinical significance: It will provide evidence to manage dentine hypersensitivity in older adults in clinical care.
288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.
This study's planned enrollment of 166 is above the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
38% silver diamine fluoride solution
Device: SDF
5% potassium nitrate solution
Device: KNO3
38% silver diamine fluoride solution
5% potassium nitrate solution
Change in dentine hypersensitivity
the percentage of change in self-perceived sensitivity score (SS)
Time frame: at 8-week follow-up
Change in oral hygiene status
the percentage of change in visible plaque index
Time frame: at 8-week follow-up
Plan to share: No
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