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

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

Study Overview

• Status: Recruiting
• Conditions: Hypersensitivity Dentin; Fluoride Varnishes
• Intervention / Treatment: Device: Resin/rosin-based varnish, 22,600 ppm NaF; Device: Aqueous fluoride varnish, 9,500 ppm NaF

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernando Zurita, DDS; Phone Number: +56996403566; Email: proyectonccl@gmail.com

Study Locations

• Chile
  • Región del Biobío
    • Concepción, Región del Biobío, Chile, 4070420
      • Recruiting
      • Clinica de Rehabilitación Avanzada e Implantologia (CRAI)
      • Contact: Fernando Zurita, DDS; Phone Number: +56996403566; Email: proyectonccl@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Resin/rosin-based varnish, 22,600 ppm NaF (Duraphat® Fluoride Varnish); 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.	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.
Experimental: Aqueous fluoride varnish, 9,500 ppm NaF (Clinpro Clear® Fluoride Varnish); 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dentin hypersensitivity to mechanical stimulation from baseline to post-fluoride varnish application	Visual Analogue Scale (VAS) With the tooth isolated and dry, a curved dental probe will be gently passed in a mesiodistal direction across the lesion area. Pain perception will be assessed using a VAS, on which the patient indicates the perceived pain intensity, ranging from no pain (0) to the worst pain imaginable (100). The score, measured on a 0-100 mm scale, will be recorded for each lesion.	Baseline; 7 and 28 days after the intervention.
Change in dentin hypersensitivity to air stimulation from baseline to post-fluoride varnish application	Air blast test (Schiff test) An air stimulus will be applied for 4 seconds from a distance of 3-4 mm using a triple syringe with standardized air pressure (40-60 psi) at room temperature. In cases of cervical lesions on adjacent teeth, neighboring lesions will be isolated with cotton to ensure tooth-specific responses. Pain response will be assessed using the Schiff sensitivity scale: Score 0: No response to the air stimulus.; Score 1: A response is perceived, but the subject does not request discontinuation of the stimulus and does not move away.; Score 2: A response is perceived and the subject requests discontinuation of the stimulus or involuntarily moves away.; Score 3: An intense pain response occurs, with immediate request to stop the stimulus or marked withdrawal from it.	Baseline; 7 and 28 days after the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oral health-related quality of life from baseline to post-fluoride varnish application	This outcome will be measured using a validated translation to Spanish of the Oral Health Impact Profile (OHIP-14), evaluating the impact of dentin hypersensitivity on quality of life across seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Patients report how frequently they experienced dentin hypersensitivity-related problems using a 5-point Likert scale (0 = never to 4 = very often). Total scores range from 0-56, with higher scores indicating poorer oral health-related quality of life.	Baseline; 28 days after intervention
Patient satisfaction following fluoride varnish application	Client Satisfaction Assessment Tool (CSAT) CSAT will assess patient satisfaction using three items evaluating comfort during fluoride varnish application, ease of adherence to post-application instructions, and likelihood of recommending the treatment to others with dentin hypersensitivity. Each item is rated on a 5-point Likert scale ranging from negative to positive perceptions (1 = very uncomfortable/difficult/improbable to 5 = very comfortable/easy/probable), with higher scores indicating greater patient satisfaction.	7 days after intervention.

Collaborators and Investigators

• Sponsor: University of Concepcion, Chile
• Collaborators: Solventum
• Investigators: Principal Investigator: Sebastian Muñoz, DDS, Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion; Study Director: Michael Wendler, DDS, PhD, Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion

Publications and helpful links

General Publications

• Tenuta LMA, Capalbo LC, Yoshino EY. Enamel Fluoride Reactivity of Professional Fluoride Products Is Not Correlated With Their Total Fluoride Content. Pediatr Dent. 2025 May 15;47(3):178-182.
• Sharan A, Pawar B, Bagde H, Chawla TK, Dhan AV, Shyamsukha B, Sharma S. Comparative Evaluation of Dentin Hypersensitivity Reduction Over One Month after a Single Topical Application of Three Different Materials: A Prospective Experimental Study. J Pharm Bioallied Sci. 2024 Dec;16(Suppl 4):S3405-S3407. doi: 10.4103/jpbs.jpbs_848_24. Epub 2024 Oct 29.
• Sgreccia PC, Dame-Teixeira N, Barbosa RES, Araujo PF, Zanatta RF, Garcia FCP. Assessment of the Oral Health Impact Profile (OHIP-14) improvement of different treatments for dentin hypersensitivity in noncarious cervical lesions-a randomized clinical study. Clin Oral Investig. 2022 Nov;26(11):6583-6591. doi: 10.1007/s00784-022-04610-x. Epub 2022 Jul 7.
• Porto IC, Andrade AK, Montes MA. Diagnosis and treatment of dentinal hypersensitivity. J Oral Sci. 2009 Sep;51(3):323-32. doi: 10.2334/josnusd.51.323.
• Machado AC, Maximiano V, Yoshida ML, Freitas JG, Mendes FM, Aranha ACC, Scaramucci T. Efficacy of a calcium-phosphate/fluoride varnish and ionomeric sealant on cervical dentin hypersensitivity: A randomized, double-blind, placebo-controlled clinical study. J Oral Rehabil. 2022 Jan;49(1):62-70. doi: 10.1111/joor.13270. Epub 2021 Nov 2.
• Lopez R, Baelum V. Spanish version of the Oral Health Impact Profile (OHIP-Sp). BMC Oral Health. 2006 Jul 7;6:11. doi: 10.1186/1472-6831-6-11.
• Garofalo SA, Sakae LO, Machado AC, Cunha SR, Zezell DM, Scaramucci T, Aranha AC. In Vitro Effect of Innovative Desensitizing Agents on Dentin Tubule Occlusion and Erosive Wear. Oper Dent. 2019 Mar/Apr;44(2):168-177. doi: 10.2341/17-284-L. Epub 2018 Jun 28.
• Fernandez CE, Tenuta LM, Zarate P, Cury JA. Insoluble NaF in Duraphat(R) may prolong fluoride reactivity of varnish retained on dental surfaces. Braz Dent J. 2014;25(2):160-4. doi: 10.1590/0103-6440201302405.
• Douglas-de-Oliveira DW, Vitor GP, Silveira JO, Martins CC, Costa FO, Cota LOM. Effect of dentin hypersensitivity treatment on oral health related quality of life - A systematic review and meta-analysis. J Dent. 2018 Apr;71:1-8. doi: 10.1016/j.jdent.2017.12.007. Epub 2017 Dec 17.
• Dall Agnol MA, Battiston C, Tenuta LMA, Cury JA. Fluoride Formed on Enamel by Fluoride Varnish or Gel Application: A Randomized Controlled Clinical Trial. Caries Res. 2022;56(1):73-80. doi: 10.1159/000521454. Epub 2021 Dec 13.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): June 26, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Estimated): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Desensitizing agents; Dentin hypersensitivity; OHIP-14; Visual analogue scale (VAS); Fluoride varnishes; Schiff scale; Aqueous fluoride varnish
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dentin Sensitivity
• Other Study ID Numbers: CEC-SSC 25-10-120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared. Only aggregated and de-identified summary data may be included in publications and scientific presentations. IPD will not be shared because the study is small in scale, involves sensitive clinical information, and sharing participant-level data may pose privacy risks that cannot be fully mitigated. Additionally, the research objectives can be addressed through summary-level reporting without requiring access to individual datasets.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes