Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Dentine Hypersensitivity

Intervention / Treatment
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* Device: SDF
* Device: KNO3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SDF<br>38% silver diamine fluoride solution | Device: SDF<br>* 38% silver diamine fluoride solution<br>|
| Active Comparator: KNO3<br>5% potassium nitrate solution | Device: KNO3<br>* 5% potassium nitrate solution<br>|

What is the study measuring?
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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 |