NCT05392868

Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

A Clinical Protocol on the Effectiveness of 38% Silver Diamine Fluoride in Reducing Dentine Hypersensitivity on Exposed Root Surface in Older Chinese Adults

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Dentine Hypersensitivity

Interventions

Type	Name	Description
DEVICE	SDF	38% silver diamine fluoride solution
DEVICE	KNO3	5% potassium nitrate solution

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-11-30
• Completion: 2024-02-28
• First posted: 2022-05-26
• Last updated: 2023-07-25

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study