Enamel Fluoride Reactivity of Professional Fluoride Products Is Not Correlated With Their Total Fluoride Content.
Livia Maria Andaló Tenuta, Letícia Cabrera Capalbo, Elaine Yamada Yoshino
https://pubmed.ncbi.nlm.nih.gov/40533917Actively Recruiting
Phase Not Applicable
Age: 18Years - 40Years
All Genders
ID07286344
Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity: A Randomized Clinical Trial
Led by University of Concepcion, Chile · Updated on 2026-06-02
92
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University of Concepcion, Chile
Lead Sponsor
S
Solventum
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial evaluates the effect of two different fluoride varnish formulations on dentin hypersensitivity (DH) in young adults diagnosed with this condition. Researchers aim to determine if Clinpro Clear4 (aqueous base, 9,500 ppm NaF) reduces DH more than Duraphat4 (rosin/resin base, 22,600 ppm NaF), and whether these treatments improve oral health-related quality of life and patient satisfaction. The study is a randomized controlled clinical trial comparing these two commercially available varnishes. Participants will receive a single application of either Duraphat4 or Clinpro Clear4 under standardized conditions. For Duraphat4, the tooth surface is cleaned, and a thin film is applied with a cotton applicator; patients keep lip retractors in place for 15 minutes and avoid brushing or hard foods for 4 hours. For Clinpro Clear4, the tooth is cleaned and dried, varnish is applied with a brush to cover the sensitive area, and patients also keep lip retractors for 15 minutes without disturbing the varnish. During the study, participants will complete baseline and follow-up assessments at 7 and 28 days after application. These include measuring dentin hypersensitivity intensity using a visual analogue scale and Schiff scale, evaluating oral health-related quality of life with the OHIP-14 questionnaire, and assessing patient satisfaction using the CSAT survey. The study runs from baseline through 28 days post-treatment with careful monitoring of outcomes and participant experiences.
CONDITIONS
Brief Title
Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity
Who Can Participate
Age: 18Years - 40Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 40 years
- No systemic diseases with oral effects or medications causing dry mouth
- Fully dentate except for wisdom teeth or extractions for orthodontics
- No active or unstable periodontal disease
- At least one cervical lesion with Schiff sensitivity score of 1 or higher
- No prior treatment or restorations on target lesions, including no topical fluoride in last 6 months
You will not qualify if you...
- Need for long-term use of NSAIDs or other pain/anti-inflammatory drugs
- Allergy to milk proteins
- Allergy to organic resins or pine-derived substances
- Pregnant or breastfeeding
- Having fixed orthodontic appliances in place
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single application visit
Participants receive fluoride varnish applied to the hypersensitive tooth area. The tooth surface will be cleaned and dried, then the varnish will be applied using a brush or cotton applicator. Participants remain seated with lip retractors in place for 15 minutes and will be advised to avoid brushing teeth or hard foods for at least 4 hours after application.
1 visit (in-person)
Follow-up
Duration - 28 days
Participants are assessed for changes in dentin hypersensitivity and oral health-related quality of life after fluoride varnish application.
2 visits (at 7 and 28 days post-application)
Trial Site Locations
Total: 1 location
1
Clinica de Rehabilitación Avanzada e Implantologia (CRAI)
Concepción, Biobio, Chile, 4070420
Actively Recruiting
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Research Team
F
Fernando Zurita, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Comparative Evaluation of Dentin Hypersensitivity Reduction Over One Month after a Single Topical Application of Three Different Materials: A Prospective Experimental Study.
Aniket Sharan, Babita Pawar, Hiroj Bagde...
https://pubmed.ncbi.nlm.nih.gov/39926954Assessment of the Oral Health Impact Profile (OHIP-14) improvement of different treatments for dentin hypersensitivity in noncarious cervical lesions-a randomized clinical study.
Paula Cesar Sgreccia, Nailê Damé-Teixeira, Rodrigo Edson Santos Barbosa...
https://pubmed.ncbi.nlm.nih.gov/35796800Diagnosis and treatment of dentinal hypersensitivity.
Isabel C C M Porto, Ana K M Andrade, Marcos A J R Montes
https://pubmed.ncbi.nlm.nih.gov/19776498Efficacy of a calcium-phosphate/fluoride varnish and ionomeric sealant on cervical dentin hypersensitivity: A randomized, double-blind, placebo-controlled clinical study.
Alana Cristina Machado, Vinícius Maximiano, Mirian Lumi Yoshida...
https://pubmed.ncbi.nlm.nih.gov/34676918Spanish version of the Oral Health Impact Profile (OHIP-Sp).
Rodrigo Lopez, Vibeke Baelum
https://pubmed.ncbi.nlm.nih.gov/16827940In Vitro Effect of Innovative Desensitizing Agents on Dentin Tubule Occlusion and Erosive Wear.
S A Garofalo, L O Sakae, A C Machado...
https://pubmed.ncbi.nlm.nih.gov/29953338Insoluble NaF in Duraphat® may prolong fluoride reactivity of varnish retained on dental surfaces.
Constanza Estefany Fernández, Livia Maria Andaló Tenuta, Paulo Zárate...
https://pubmed.ncbi.nlm.nih.gov/25140722Effect of dentin hypersensitivity treatment on oral health related quality of life - A systematic review and meta-analysis.
Dhelfeson Willya Douglas-de-Oliveira, Glayson Pereira Vitor, Juliana Oliveira Silveira...
https://pubmed.ncbi.nlm.nih.gov/29262305Fluoride Formed on Enamel by Fluoride Varnish or Gel Application: A Randomized Controlled Clinical Trial.
Mauro Antonio Dall Agnol, Carla Battiston, Livia Maria Andalo Tenuta...
https://pubmed.ncbi.nlm.nih.gov/34915485