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NCT Number: NCT07286344

Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity

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

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Key information

Conditions

Hypersensitivity Dentin Dentin Sensitivity Fluoride Varnishes Stomatognathic Diseases Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica de Rehabilitación Avanzada e Implantologia (CRAI)

Concepción, Biobio, 4070420, Chile

Location status: Recruiting

Location contact

Fernando Zurita, DDS

CONTACT

[email protected]

+56996403566

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Aqueous fluoride varnish, 9,500 ppm NaF

Device

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 NaF

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in oral health-related quality of life from baseline to post-fluoride varnish application

    Time frame: Baseline; 28 days after intervention

    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.

  2. Patient satisfaction following fluoride varnish application

    Time frame: 7 days after intervention.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fernando Zurita, DDS

CONTACT

[email protected]

+56996403566

Sponsors and collaborators

Lead sponsor

University of Concepcion, Chile

Other

Collaborators

  • Solventum

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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