Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Concepcion, Chile
About this 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:
* 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Aqueous fluoride varnish, 9,500 ppm NaF
DeviceThe 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
DeviceThe 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.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Resin/rosin-based varnish, 22,600 ppm NaF (Duraphat® Fluoride Varnish)Active comparator 1 intervention
Group B: Aqueous fluoride varnish, 9,500 ppm NaF (Clinpro Clear® Fluoride Varnish)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.Secondary outcomes
1
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 intervention2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Concepcion, Chile
Lead sponsor
Solventum
Collaborator
Source ClinicalTrials.gov