Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity
Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity: A Randomized Clinical Trial
University of Concepcion, Chile
92 participants
Dec 4, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- 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 Criteria5
- 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
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Interventions
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.
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.
Locations(1)
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NCT07286344