Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity

NCT07286344 | Recruiting FDA Device

• 1 other identifier: CEC-SSC 25-10-120
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dentin hypersensitivity; Fluoride varnishes; Visual analogue scale (VAS); Schiff scale; OHIP-14; Desensitizing agents; Aqueous fluoride varnish

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in oral health-related quality of life from baseline to post-fluoride varnish application

  Baseline; 28 days after intervention

• Patient satisfaction following fluoride varnish application

  7 days after intervention.

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

Interventions

Aqueous fluoride varnish, 9,500 ppm NaF DEVICE

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.

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

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

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.

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Concepcion, Chile: lead
• Solventum: collaborator

Study Sites (1)

Clinica de Rehabilitación Avanzada e Implantologia (CRAI)

Concepción, Región del Biobío, 4070420, Chile

RECRUITING

Related Publications (10)

• 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.

  PMID: 40533917 RESULT

• 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.

  PMID: 39926954 RESULT

• 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.

  PMID: 35796800 RESULT

• 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.

  PMID: 19776498 RESULT

• 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.

  PMID: 34676918 RESULT

• 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.

  PMID: 16827940 RESULT

• 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.

  PMID: 29953338 RESULT

• 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.

  PMID: 25140722 RESULT

• 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.

  PMID: 29262305 RESULT

• 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.

  PMID: 34915485 RESULT

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sebastian Muñoz, DDS

  Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion

  PRINCIPAL INVESTIGATOR

• Michael Wendler, DDS, PhD

  Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion

  STUDY DIRECTOR

Central Study Contacts

Fernando Zurita, DDS

CONTACT

+56996403566; proyectonccl@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled clinical trial with parallel arms

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 16, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): June 26, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)