Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity

Summary

This randomized controlled clinical trial aims to determine whether different fluoride varnish formulations reduce dentin hypersensitivity (DH) in young adults diagnosed with DH. The primary purpose of this study is to evaluate the clinical effectiveness of two commercially available fluoride varnishes.

The main questions this study aims to answer are:

* Does Clinpro Clear® (aqueous base, 9,500 ppm NaF) lead to a greater reduction in dentin hypersensitivity compared with Duraphat® (rosin/resin base, 22,600 ppm NaF)?
* Do these varnish formulations improve oral health-related quality of life and patient satisfaction?

Researchers will compare a single application of Duraphat® with a single application of Clinpro Clear® to assess differences in hypersensitivity reduction, quality-of-life outcomes, and patient satisfaction.

Participants will:

* Receive one application of either Duraphat® or Clinpro Clear® under standardized clinical conditions.
* Complete baseline and post-treatment evaluations, including:
* Dentin hypersensitivity intensity using a visual analogue scale (VAS)
* Air-blast response using the Schiff scale
* Oral health-related quality of life using the OHIP-14
* Patient satisfaction using the CSAT survey

Conditions

• Hypersensitivity Dentin
• Fluoride Varnishes

Interventions

DEVICE

Aqueous fluoride varnish, 9,500 ppm NaF

The tooth surface will be cleaned and dried with a lip retractor in place. The varnish will be dispensed into the unit-dose chamber and applied with a brush to fully cover the hypersensitive area. Patients will be instructed not to disturb the varnish and will remain with the lip retractors in place for 15 minutes.

DEVICE

Resin/rosin-based varnish, 22,600 ppm NaF

The tooth surface will be cleaned and dried, and the varnish will be dispensed onto an application tray. A thin film will be applied using a cotton applicator, probe, or brush. Patients will remain seated with lip retractors in place for 15 minutes and will be advised to avoid toothbrushing and hard foods for at least 4 hours after application.

Sponsors & Collaborators

• Solventum

  collaborator INDUSTRY

• University of Concepcion, Chile

  lead OTHER

Principal Investigators

• Sebastian Muñoz, DDS · Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion

• Michael Wendler, DDS, PhD · Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-04

Primary Completion

2026-05-29

Completion

2026-06-26

FDA Device

Yes

Countries

• Chile

Study Locations