Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

Sponsor

The University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05392868

Collaborator

(none)

166

Enrollment

Location

Arms

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dentine Hypersensitivity	Device: SDF Device: KNO3	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SDF 38% silver diamine fluoride solution	Device: SDF 38% silver diamine fluoride solution
Active Comparator: KNO3 5% potassium nitrate solution	Device: KNO3 5% potassium nitrate solution

Arm

Intervention/Treatment

Experimental: SDF

38% silver diamine fluoride solution

Device: SDF

38% silver diamine fluoride solution

Active Comparator: KNO3

5% potassium nitrate solution

Device: KNO3

5% potassium nitrate solution

Outcome Measures

Primary Outcome Measures

Change in dentine hypersensitivity [at 8-week follow-up]
the percentage of change in self-perceived sensitivity score (SS)

Secondary Outcome Measures

Change in oral hygiene status [at 8-week follow-up]
the percentage of change in visible plaque index

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Hong Kong	Hong Kong		China

Sponsors and Collaborators

The University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chun-Hung Chu, Clinical Professor, The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT05392868

Other Study ID Numbers:

HKU2022

First Posted:

May 26, 2022

Last Update Posted:

Jun 2, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Dentin Sensitivity

Hypersensitivity

Study Results

No Results Posted as of Jun 2, 2022