Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

The University of Hong Kong (HKU)

Status and phase: Enrolling; Phase 2

Conditions: Dentine Hypersensitivity

Treatments: Device: SDF; Device: KNO3

Study type: Interventional

Funder types: Other

Identifiers

NCT05392868

HKU2022

Details and patient eligibility

About

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.

Enrollment: 166 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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166 participants in 2 patient groups

SDF

Experimental group

Description:

38% silver diamine fluoride solution

Treatment:

Device: SDF

KNO3

Active Comparator group

Description:

5% potassium nitrate solution

Treatment:

Device: KNO3