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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05392868
Enrollment
166
Registered
2022-05-26
Start date
2023-02-01
Completion date
2024-02-28
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentine Hypersensitivity

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.

Interventions

DEVICESDF

38% silver diamine fluoride solution

DEVICEKNO3

5% potassium nitrate solution

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in dentine hypersensitivityat 8-week follow-upthe percentage of change in self-perceived sensitivity score (SS)

Secondary

MeasureTime frameDescription
Change in oral hygiene statusat 8-week follow-upthe percentage of change in visible plaque index

Countries

China

Contacts

Primary ContactChun Hung Chu, PhD
chchu@hku.hk(+852)28590287

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026