Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity (NCT07286344) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Fluoride Varnish Formulation on the Management of Dentin Hypersensitivity
Chile92 participantsStarted 2025-12-04
Plain-language 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.
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
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in dentin hypersensitivity to mechanical stimulation from baseline to post-fluoride varnish application
Timeframe: Baseline; 7 and 28 days after the intervention.
2
Change in dentin hypersensitivity to air stimulation from baseline to post-fluoride varnish application
Timeframe: Baseline; 7 and 28 days after the intervention.