Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults
Primary Purpose
Dentine Hypersensitivity
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SDF
KNO3
Sponsored by
About this trial
This is an interventional treatment trial for Dentine Hypersensitivity
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
Sites / Locations
- The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SDF
KNO3
Arm Description
38% silver diamine fluoride solution
5% potassium nitrate solution
Outcomes
Primary Outcome Measures
Change in dentine hypersensitivity
the percentage of change in self-perceived sensitivity score (SS)
Secondary Outcome Measures
Change in oral hygiene status
the percentage of change in visible plaque index
Full Information
NCT ID
NCT05392868
First Posted
May 22, 2022
Last Updated
July 23, 2023
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05392868
Brief Title
Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentine Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SDF
Arm Type
Experimental
Arm Description
38% silver diamine fluoride solution
Arm Title
KNO3
Arm Type
Active Comparator
Arm Description
5% potassium nitrate solution
Intervention Type
Device
Intervention Name(s)
SDF
Intervention Description
38% silver diamine fluoride solution
Intervention Type
Device
Intervention Name(s)
KNO3
Intervention Description
5% potassium nitrate solution
Primary Outcome Measure Information:
Title
Change in dentine hypersensitivity
Description
the percentage of change in self-perceived sensitivity score (SS)
Time Frame
at 8-week follow-up
Secondary Outcome Measure Information:
Title
Change in oral hygiene status
Description
the percentage of change in visible plaque index
Time Frame
at 8-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun Hung Chu, PhD
Phone
(+852)28590287
Email
chchu@hku.hk
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Hung Chu
Phone
00852-28590287
Email
chchu@hku.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36286004
Citation
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.
Results Reference
derived
Learn more about this trial
Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults
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