Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

NCT05392868 | Unknown Phase 2 FDA Device

• 1 other identifier: HKU2022
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentine Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Change in dentine hypersensitivity

  the percentage of change in self-perceived sensitivity score (SS)

  at 8-week follow-up

Secondary Outcomes (1)

• Change in oral hygiene status

  at 8-week follow-up

Study Arms (2)

SDF

EXPERIMENTAL

38% silver diamine fluoride solution

Device: SDF

KNO3

ACTIVE COMPARATOR

5% potassium nitrate solution

Device: KNO3

Interventions

SDF DEVICE

38% silver diamine fluoride solution

SDF

KNO3 DEVICE

5% potassium nitrate solution

KNO3

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• generally healthy;
• no known or suspected allergy to the study ingredients or materials
• have all active dental diseases under control but reported hypersensitivity

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 37454789 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.

  PMID: 36286004 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Chun Hung Chu, PhD

CONTACT

(+852)28590287; chchu@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: May 26, 2022
• Study Start: February 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: February 28, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)