Comparing Clinpro Clear and Duraphat varnishes for dentin hypersensitivity in young adults
Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity: A Randomized Clinical Trial
NA · University of Concepcion, Chile · NCT07286344
This test will see if a single application of Clinpro Clear or Duraphat reduces dentin hypersensitivity in adults aged 18–40.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Concepcion, Chile (other) |
| Locations | 1 site (Concepción, Biobio) |
| Trial ID | NCT07286344 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial enrolls adults 18–40 with at least one cervical lesion and a Schiff sensitivity score ≥1 and randomly assigns them to a single application of either Clinpro Clear (aqueous, 9,500 ppm NaF) or Duraphat (rosin/resin-based, 22,600 ppm NaF) under standardized clinical conditions. Sensitivity outcomes will be measured at baseline and after treatment using the Schiff scale and visual analogue scales, and oral health–related quality of life and patient satisfaction will be recorded with OHIP-14 and satisfaction questionnaires. The protocol excludes pregnant or breastfeeding individuals, those with resin or pine allergies, long-term analgesic use, or fixed orthodontic appliances. The trial compares immediate and short-term changes in symptoms and quality-of-life metrics between the two commercially available varnish formulations.
Who should consider this trial
Good fit: Ideal candidates are dentally healthy adults aged 18–40 with at least one untreated cervical lesion causing measurable sensitivity (Schiff ≥1) who can attend the clinic in Concepción and have no resin or pine allergies.
Not a fit: Patients who are pregnant or breastfeeding, have allergies to organic resins or pine, require long-term analgesics, have fixed orthodontic appliances, or have prior restorative treatment on the target lesion are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could identify a simple, single-visit varnish option that reduces dentin hypersensitivity and improves oral quality of life.
How similar studies have performed: Previous trials show that fluoride varnishes can reduce dentin hypersensitivity, but head-to-head data comparing these specific formulations are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Concepción, Biobio
- Clinica de Rehabilitación Avanzada e Implantologia (CRAI) — Concepción, Biobio, Chile (RECRUITING)
Study contacts
- Principal investigator: Sebastian Muñoz, DDS — Department of Restorative Dentistry, Faculty of Dentistry, Universidad de Concepcion
- Study coordinator: Fernando Zurita, DDS
- Email: proyectonccl@gmail.com
- Phone: +56996403566
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypersensitivity Dentin, Fluoride Varnishes, Dentin hypersensitivity, Fluoride varnishes, Visual analogue scale, Schiff scale, OHIP-14, Desensitizing agents