Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

Dentine Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05392868
• Other study ID #: HKU2022
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: July 2023
• Source: The University of Hong Kong
• Contact: Chun Hung Chu, PhD
• Phone: (+852)28590287
• Email: chchu[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: February 28, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dentin Sensitivity
• Dentine Hypersensitivity
• Hypersensitivity

Intervention

Device:
• SDF
38% silver diamine fluoride solution
• KNO3
5% potassium nitrate solution

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dentine hypersensitivity	the percentage of change in self-perceived sensitivity score (SS)	at 8-week follow-up
Secondary	Change in oral hygiene status	the percentage of change in visible plaque index	at 8-week follow-up