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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05392868
Other study ID # HKU2022
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
See also
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Completed NCT02018783 - Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment N/A
Completed NCT01592851 - Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity Phase 3