NCT05392868

Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

Status unknown Phase 2 Last updated 25 July 2023

What this trial tests

Phase 2 trial testing SDF in Dentine Hypersensitivity in 166 participants. Status unknown.

Timeline

1 February 2023

Primary endpoint
30 November 2023

28 February 2024

Quick facts

Lead sponsor	The University of Hong Kong
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	166
Start date	1 February 2023
Primary completion	30 November 2023
Estimated completion	28 February 2024
Sites	1 location across China

Drugs / interventions tested

• SDF — full drug profile →
• KNO3 — full drug profile →

Conditions studied

• Dentine Hypersensitivity — all drugs for Dentine Hypersensitivity →

Sponsor

The University of Hong Kong

Who can join

Adults 65 to 100, any sex, with Dentine Hypersensitivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treating hypersensitivity in older adults with silver diamine fluoride: A randomised clinical trial.
   Chan AKY, Tsang YC, Jiang CM, Leung KCM, et al · · 2023 · cited 9× · PMID 37454789 · DOI 10.1016/j.jdent.2023.104616
2. Effectiveness of 38% Silver Diamine Fluoride in Reducing Dentine Hypersensitivity on Exposed Root Surface in Older Chinese Adults: Study Protocol for a Randomised Double-Blind Study.
   Chan AKY, Tamrakar M, Jiang CM, Tsang YC, et al · · 2022 · cited 7× · PMID 36286004 · DOI 10.3390/dj10100194