Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity

University of Concepcion, Chile

Status: Enrolling

Conditions: Fluoride Varnishes; Hypersensitivity Dentin

Treatments: Device: Resin/rosin-based varnish, 22,600 ppm NaF; Device: Aqueous fluoride varnish, 9,500 ppm NaF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07286344

CEC-SSC 25-10-120

Details and patient eligibility

About

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

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 40 years
• Absence of systemic diseases with oral manifestations or requiring medications with antisialagogue effects
• Fully dentate (excluding third molars or teeth extracted for orthodontic reasons)
• Absence of periodontal disease, or periodontal condition in a stable state
• Presence of at least one cervical lesion with a Schiff sensitivity score ≥ 1
• No previous treatment or restorative procedures on the target lesions (including no topical fluoride application within the last 6 months)

Exclusion criteria

• Patients requiring long-term use of NSAIDs or other analgesic/anti-inflammatory medications
• Patients with allergy to milk proteins
• Patients with allergy to organic resins or pine-derived substances
• Pregnant or breastfeeding individuals
• Patients with fixed orthodontic appliances in place

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

Resin/rosin-based varnish, 22,600 ppm NaF (Duraphat® Fluoride Varnish)

Active Comparator group

Description:

Application procedure: * The tooth surface will be cleaned and saliva gently removed. * The appropriate amount of varnish will be dispensed onto an application tray. * The varnish will be applied with a cotton applicator, probe, or brush, forming a thin film. * The patient will remain seated with lip retractors in place for 15 minutes. * Patients will be instructed not to brush their teeth or chew hard foods for at least 4 hours post-application.

Treatment:

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

Aqueous fluoride varnish, 9,500 ppm NaF (Clinpro Clear® Fluoride Varnish)

Experimental group

Description:

Application procedure: * The tooth surface will be cleaned and dried; a lip retractor will be used. * The varnish will be expressed fully into the dispensing chamber of the unit-dose package. * Using the applicator brush, the varnish will be applied to fully cover the hypersensitive area. * Patients will be instructed not to touch the teeth with the tongue or attempt to remove the varnish. * After application, patients will remain with lip retractors in place for 15 minutes.

Treatment:

Device: Aqueous fluoride varnish, 9,500 ppm NaF