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

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.

Study Overview

• Status: Recruiting
• Conditions: Dentine Hypersensitivity
• Intervention / Treatment: Device: SDF; Device: KNO3

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chun Hung Chu, PhD; Phone Number: (+852)28590287; Email: chchu@hku.hk

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • The University of Hong Kong
    • Contact: Chun Hung Chu; Phone Number: 00852-28590287; Email: chchu@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• generally healthy;
• no known or suspected allergy to the study ingredients or materials
• have all active dental diseases under control but reported hypersensitivity

Exclusion Criteria:

• using any desensitizing agent within one month
• have major systemic diseases such as cancer
• receive medications that may affect pain perception within one month
• have dentine hypersensitivity due to other dental conditions such as caries
• are not able to give written consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SDF; 38% silver diamine fluoride solution	Device: SDF; 38% silver diamine fluoride solution
Active Comparator: KNO3; 5% potassium nitrate solution	Device: KNO3; 5% potassium nitrate solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dentine hypersensitivity	the percentage of change in self-perceived sensitivity score (SS)	at 8-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oral hygiene status	the percentage of change in visible plaque index	at 8-week follow-up

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Publications and helpful links

General Publications

• Chan AKY, Tamrakar M, Jiang CM, Tsang YC, Leung KCM, Chu CH. 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. Dent J (Basel). 2022 Oct 19;10(10):194. doi: 10.3390/dj10100194.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: May 22, 2022
• First Submitted That Met QC Criteria: May 22, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 23, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: HKU2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes