Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

Phase 2

Recruiting

• Conditions: Dentine Hypersensitivity
• Interventions: Device: KNO3; Device: SDF

• Registration Number: NCT05392868
• Lead Sponsor: The University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-05-22
• Study First Posted: 2022-05-26
• Study Start: 2023-02-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-23
• Last Update Posted: 2023-07-25
• Primary Completion: 2023-11-30
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 166

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KNO3	KNO3	5% potassium nitrate solution
SDF	SDF	38% silver diamine fluoride solution

Primary Outcome Measures

Name	Time	Method
Change in dentine hypersensitivity	at 8-week follow-up	the percentage of change in self-perceived sensitivity score (SS)

Secondary Outcome Measures

Name	Time	Method
Change in oral hygiene status	at 8-week follow-up	the percentage of change in visible plaque index

Trial Locations

Locations (1)

The University of Hong Kong; 🇨🇳 Hong Kong, China