Hypersensitivity DentinNCT07286344
Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity
A study testing Aqueous fluoride varnish, 9,500 ppm NaF and Resin/rosin-based varnish, 22,600 ppm NaF in people with Hypersensitivity Dentin and Fluoride Varnishes, run by University of Concepcion, Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Hypersensitivity Dentin, Fluoride Varnishes
- What is being tested?
- Aqueous fluoride varnish, 9,500 ppm NaF and Resin/rosin-based varnish, 22,600 ppm NaF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChile
- Study dates
- 4 Dec 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Clinica de Rehabilitación Avanzada e Implantologia (CRAI)
Concepción, Biobio, 4070420
Fernando Zurita, DDS, +56996403566, proyectonccl@gmail.com
About this study
Official title: 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:
Read more
- 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
- Being tested
- Aqueous fluoride varnish, 9,500 ppm NaF, Resin/rosin-based varnish, 22,600 ppm NaF
- Keywords
- Dentin hypersensitivity, Fluoride varnishes, Visual analogue scale (VAS), Schiff scale, OHIP-14, Desensitizing agents, Aqueous fluoride varnish
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqueous fluoride varnish, 9,500 ppm NaFDevice
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 NaFDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Aqueous fluoride varnish, 9,500 ppm NaF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 7 days after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start4 Dec 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity DentinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial with parallel arms
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Concepcion, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Solventum
- Responsible party
- Principal investigator, Michael Wendler Ernst, University of Concepcion, Chile
- Investigators
- Sebastian Muñoz, DDS, Principal investigator, Department of Restorative Dentistry, Faculty of Dentistry, Universidad de ConcepcionMichael Wendler, DDS, PhD, Study director, Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286344
- Sponsor's protocol ID
- CEC-SSC 25-10-120
- Status last verified
- May 2026
- First submitted
- 10 Dec 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
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.
PubMed 40533917Sharan 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.
PubMed 39926954Sgreccia 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.
PubMed 35796800Porto 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.
PubMed 19776498Machado 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.
PubMed 34676918Lopez 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.
PubMed 16827940Garofalo 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.
PubMed 29953338Fernandez 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.
PubMed 25140722Douglas-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.
PubMed 29262305Dall 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.
PubMed 34915485
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07286344
- Acronym / sponsor ID
- CEC-SSC 25-10-120
- Conditions
- Hypersensitivity Dentin, Fluoride Varnishes
- Keywords
- Dentin hypersensitivity, Fluoride varnishes, Visual analogue scale (VAS), Schiff scale, OHIP-14, Desensitizing agents, Aqueous fluoride varnish
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University of Concepcion, ChileUniversity, hospital or other
- Collaborators
- Solventum
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial with parallel arms
| Arm | Type | Receives |
|---|---|---|
| Resin/rosin-based varnish, 22,600 ppm NaF (Duraphat® Fluoride Varnish) | Active comparator | Device: Resin/rosin-based varnish, 22,600 ppm NaFApplication 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. |
| Aqueous fluoride varnish, 9,500 ppm NaF (Clinpro Clear® Fluoride Varnish) | Experimental | Device: Aqueous fluoride varnish, 9,500 ppm NaFApplication 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aqueous fluoride varnish, 9,500 ppm NaFThe 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. | Device | Aqueous fluoride varnish, 9,500 ppm NaF (Clinpro Clear® Fluoride Varnish) |
| Resin/rosin-based varnish, 22,600 ppm NaFThe 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. | Device | Resin/rosin-based varnish, 22,600 ppm NaF (Duraphat® Fluoride Varnish) |
Primary outcome
Change in dentin hypersensitivity to mechanical stimulation from baseline to post-fluoride varnish application
Time frame: Baseline; 7 and 28 days after the intervention.
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.
Change in dentin hypersensitivity to air stimulation from baseline to post-fluoride varnish application
Time frame: Baseline; 7 and 28 days after the intervention.
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.
2 secondary outcomes
Change in oral health-related quality of life from baseline to post-fluoride varnish application
Time frame: Baseline; 28 days after intervention
Patient satisfaction following fluoride varnish application
Time frame: 7 days after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Results publication: PubMed 40533917Tenuta 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.
- Results publication: PubMed 39926954Sharan 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.
- Results publication: PubMed 35796800Sgreccia 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.
- Results publication: PubMed 19776498Porto 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.
- Results publication: PubMed 34676918Machado 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.
- Results publication: PubMed 16827940Lopez 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.
- Results publication: PubMed 29953338Garofalo 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.
- Results publication: PubMed 25140722Fernandez 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.
- Results publication: PubMed 29262305Douglas-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.
- Results publication: PubMed 34915485Dall 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastian Muñoz, DDS principal investigator
Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion
Michael Wendler, DDS, PhD study director
Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqueous fluoride varnish, 9,500 ppm NaF and Resin/rosin-based varnish, 22,600 ppm NaF in people with Hypersensitivity Dentin and Fluoride Varnishes, run by University of Concepcion, Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando Zurita, DDS (+56996403566, proyectonccl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dentin hypersensitivity to mechanical stimulation from baseline to post-fluoride varnish application (time frame: Baseline; 7 and 28 days after the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07286344, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.