Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preventing and Arresting Dental Root Surface Caries in Community-dwelling Older Adults

NCT02360124

Dental Caries

COMPLETED PHASE2/PHASE3

Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

NCT03185104

Dental Caries Dental Caries of Root Surface

UNKNOWN NA

Fluoride Application on Preventing and Arresting Root Caries in Fluoridated and Non-fluoridated Areas

NCT02742142

Dental Caries

COMPLETED PHASE2/PHASE3

Effectiveness on SDF Solution and PVP-I Combined NaF Varnish in Preventing Root Caries in Elders

NCT03654820

Root Caries

UNKNOWN NA

Silver Diamine Fluoride and Gingivitis in Geriatric Patients

NCT03445286

Gingivitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dentine Hypersensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SDF

38% silver diamine fluoride solution

Group Type EXPERIMENTAL

SDF

Intervention Type DEVICE

38% silver diamine fluoride solution

KNO3

5% potassium nitrate solution

Group Type ACTIVE_COMPARATOR

KNO3

Intervention Type DEVICE

5% potassium nitrate solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SDF

38% silver diamine fluoride solution

Intervention Type DEVICE

KNO3

5% potassium nitrate solution

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes