Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity
NCT ID: NCT07286344
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
92 participants
INTERVENTIONAL
2025-12-04
2026-06-26
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
40 Years
ALL
No
Sponsors
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Solventum
INDUSTRY
University of Concepcion, Chile
OTHER
Responsible Party
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Michael Wendler Ernst
Associate Professor
Principal Investigators
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Sebastian Muñoz, DDS
Role: PRINCIPAL_INVESTIGATOR
Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion
Michael Wendler, DDS, PhD
Role: STUDY_DIRECTOR
Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion
Locations
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Clinica de Rehabilitación Avanzada e Implantologia (CRAI)
Concepción, Región del Biobío, Chile
Countries
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Central Contacts
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Facility Contacts
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Fernando Zurita, DDS
Role: primary
References
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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.
Other Identifiers
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CEC-SSC 25-10-120
Identifier Type: -
Identifier Source: org_study_id