Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity

Официальное название

Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity: A Randomized Clinical Trial

Обзор

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

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Change in dentin hypersensitivity to mechanical stimulation from baseline to post-fluoride varnish application [Срок оценки: Baseline; 7 and 28 days after the intervention.]
• Change in dentin hypersensitivity to air stimulation from baseline to post-fluoride varnish application [Срок оценки: Baseline; 7 and 28 days after the intervention.]

Вторичные конечные точки (2)

• Change in oral health-related quality of life from baseline to post-fluoride varnish application [Срок оценки: Baseline; 28 days after intervention]
• Patient satisfaction following fluoride varnish application [Срок оценки: 7 days after intervention.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Clinica de Rehabilitación Avanzada e Implantologia (CRAI) — Concepción

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07286344 · CEC-SSC 25-10-120

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗