Managing Dentine Hypersensitivity With Silver Diamine Flu... | NCT05392868

Studies
Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

NCT05392868

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

Jul 25, 2023Actual

Enrollment

166Estimated

Phase

Phase 2

Conditions

Dentine Hypersensitivity

Interventions

SDF
KNO3

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Nov 30, 2023Estimated

Completion Date

Feb 28, 2024Estimated

First Submitted Date

May 22, 2022

First Submission Date that Met QC Criteria

May 22, 2022

First Posted Date

May 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2023

Last Update Posted Date

Jul 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chun Hung Chu, Clinical Professor, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SDF	Experimental	38% silver diamine fluoride solution	Device: SDF
KNO3	Active Comparator	5% potassium nitrate solution	Device: KNO3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SDF	Device	38% silver diamine fluoride solution	SDF
KNO3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in dentine hypersensitivity	the percentage of change in self-perceived sensitivity score (SS)	at 8-week follow-up

Secondary Outcomes

Measure	Description	Time Frame
Change in oral hygiene status	the percentage of change in visible plaque index	at 8-week follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

100 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chun Hung Chu, PhD	Contact	(+852)28590287		chchu@hku.hk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Hong Kong	Recruiting	Hong Kong			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37454789	Derived	Chan AKY, Tsang YC, Jiang CM, Leung KCM, Lo ECM, Chu CH. Treating hypersensitivity in older adults with silver diamine fluoride: A randomised clinical trial. J Dent. 2023 Sep;136:104616. doi: 10.1016/j.jdent.2023.104616. Epub 2023 Jul 14.
36286004	Derived	Chan AKY, Tamrakar M, Jiang CM, Tsang YC, Leung KCM, Chu CH. Effectiveness of 38% Silver Diamine Fluoride in Reducing Dentine Hypersensitivity on Exposed Root Surface in Older Chinese Adults: Study Protocol for a Randomised Double-Blind Study. Dent J (Basel). 2022 Oct 19;10(10):194. doi: 10.3390/dj10100194.

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases