Dentine HypersensitivityPhase 2NCT05392868
Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults
A Phase 2 study testing SDF and KNO3 in people with Dentine Hypersensitivity, run by The University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- SDF and KNO3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 28 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- generally healthy;
- no known or suspected allergy to the study ingredients or materials
- have all active dental diseases under control but reported hypersensitivity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Chun Hung Chu, 00852-28590287, chchu@hku.hk
About this study
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
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.
- Conditions
- Dentine Hypersensitivity
- Being tested
- SDF, KNO3
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDFDevice
38% silver diamine fluoride solution
KNO3Device
5% potassium nitrate solution
| Study group | Role | What they receive |
|---|---|---|
| SDF | Experimental | 38% silver diamine fluoride solution Receives: Device: SDF |
| KNO3 | Active comparator | 5% potassium nitrate solution Receives: Device: KNO3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dentine hypersensitivity
the percentage of change in self-perceived sensitivity score (SS)
Measured: at 8-week follow-up
Secondary outcomes (1)
Change in oral hygiene status
the percentage of change in visible plaque index
Measured: at 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Feb 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dentine HypersensitivityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Hung Chu, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392868
- Sponsor's protocol ID
- HKU2022
- Status last verified
- Jul 2023
- First submitted
- 22 May 2022
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37454789Chan 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.
PubMed 36286004
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05392868
- Acronym / sponsor ID
- HKU2022
- Conditions
- Dentine Hypersensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDF | Experimental | Device: SDF38% silver diamine fluoride solution |
| KNO3 | Active comparator | Device: KNO35% potassium nitrate solution |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- generally healthy;
- no known or suspected allergy to the study ingredients or materials
- have all active dental diseases under control but reported hypersensitivity
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDF38% silver diamine fluoride solution | Device | SDF |
| KNO35% potassium nitrate solution | Device | KNO3 |
Primary outcome
Change in dentine hypersensitivity
Time frame: at 8-week follow-up
the percentage of change in self-perceived sensitivity score (SS)
1 secondary outcome
Change in oral hygiene status
Time frame: at 8-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Derived from this study: PubMed 37454789Chan 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.
- Derived from this study: PubMed 36286004Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SDF and KNO3 in people with Dentine Hypersensitivity, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun Hung Chu, PhD ((+852)28590287, chchu@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dentine hypersensitivity (time frame: at 8-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05392868, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.