An interventional study of Aqueous fluoride varnish, 9,500 ppm NaF and Resin/rosin-based varnish, 22,600 ppm NaF in Hypersensitivity Dentin and Fluoride Varnishes, sponsored by University of Concepcion, Chile. Recruiting at 1 site in Chile. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University of Concepcion, Chile · Not applicable, Interventional, and Treatment
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:
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:
288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.
This study's planned enrollment of 92 is above the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →University of Concepcion, Chile is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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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
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
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.
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.
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.
Time frame: 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.
Time frame: Baseline; 7 and 28 days after the intervention.
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.
Time frame: 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.
Time frame: 7 days after intervention.
Plan to share: 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.
Started Dec 2025 (actual). Primary completion is estimated for Jul 2026, 7 months after the start.
Of 111 non-industry interventional studies with no phase under Dentin Sensitivity, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 12. This study's planned 7 months is close to that.
Counting every sponsor, half of 144 studies reached it within 6 months; a quarter within 3 and three quarters within 10.
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University of Concepcion, Chile