An interventional study of Nanohydroxyapatite Varnish Application and Sodium Fluoride Varnish Application in Fluoride Varnishes, Molar Incisor Hypomineralisation and Permanent Anterior Teeth, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 8 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
This randomized controlled clinical trial evaluates and compares the remineralization efficacy of a 8.6% nanohydroxyapatite (nano-HAp) varnish versus a standard 5% sodium fluoride (NaF) varnish in young permanent anterior teeth affected by Molar Incisor Hypomineralization (MIH).
Twenty-six children aged 8 to 11 years presenting with non-cavitated initial carious lesions (ICDAS scores 1 or 2) on MIH-affected permanent incisors are randomly allocated into two equal groups (n = 13 per group). Group I receives topical application of nano-HAp varnish (Fygg Varnish), while Group II receives 5% NaF varnish (Profluorid Varnish). Both groups follow standardized home care using non-fluoridated toothpaste. Remineralization and lesion progression are objectively evaluated at 1, 3, and 6 months post-application using International Caries Detection and Assessment System (ICDAS) scores and laser fluorescence (DIAGNOdent) quantitative readings.
128 studies on the registry are indexed under Molar Hypomineralization; 43 are open to participants now.
This study's planned enrollment of 26 is below the median of 52 across 99 interventional studies indexed under Molar Hypomineralization.
Browse Molar Hypomineralization studies →Tanta University is the lead sponsor of 991 studies on the registry; 316 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Young permanent incisors with non-cavitated MIH enamel lesions (ICDAS 1 or 2) treated with 8.6% nanohydroxyapatite varnish.
Procedure: Nanohydroxyapatite Varnish Application
Young permanent incisors with non-cavitated MIH enamel lesions (ICDAS 1 or 2) treated with 5% sodium fluoride varnish.
Procedure: Sodium Fluoride Varnish Application
Preparation: Professional prophylaxis of target labial surface with non-fluoridated pumice and rubber cup, followed by partial isolation using cheek retractors, high-volume suction, and cotton rolls. Application: A dime-sized amount of premixed 8.6% nano-HAp varnish is dispensed on a mixing pad and swept uniformly across the labial surface using a soft brush applicator over 15 to 30 seconds. Post-Care: Standard post-application instructions (no food/drink for 30 minutes; no brushing/flossing for 4 hours; no hot drinks/alcohol for 24 hours). Home care standardized using non-fluoridated toothpaste (Dabur Herbal) twice daily.
Preparation: Identical professional prophylaxis with non-fluoridated pumice, rinsing, and moisture control isolation. Application: A thin layer of 5% NaF varnish is coated onto the target labial enamel surface using a brush applicator for 1 to 4 minutes and allowed to set upon contact with saliva. Post-Care: Identical post-application dietary restrictions and standardized home care with non-fluoridated toothpaste.
Quantitative Enamel Remineralization / Laser Fluorescence (DIAGNOdent Score)
Objective quantitative measurement of organic component breakdown and bacterial fluorescence within the enamel lesion using a calibrated DIAGNOdent device (KaVo Dental). Measured in peak numerical fluorescence units (0-99). A reduction in DIAGNOdent value relative to baseline indicates remineralization and structural mineral gain.
Time frame: Baseline (pre-application), 1 month, 3 months, and 6 months post-application.
Visual Caries Lesion Severity (ICDAS Score)
Clinical visual assessment of non-cavitated MIH enamel lesions categorized according to the International Caries Detection and Assessment System (ICDAS) criteria following a 5-second air-drying step: Score 0: Sound tooth surface Score 1: First visual change in enamel (seen only after prolonged air drying) Score 2: Distinct visual change in enamel (visible when wet) Lower scores reflect lesion regression/remineralization; stable scores represent arrestment.
Time frame: Baseline (pre-application), 1 month, 3 months, and 6 months post-application.
Started Jan 2026 (actual). Primary completion is estimated for Nov 2026, 10 months after the start.
Of 58 non-industry interventional studies with no phase under Molar Hypomineralization, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 25. This study's planned 10 months is below that.
Counting every sponsor, half of 58 studies reached it within 14 months; a quarter within 10 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.