Fluoride VarnishesNCT07894510
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
A study testing Nanohydroxyapatite Varnish Application and Sodium Fluoride Varnish Application in people with Fluoride Varnishes and Molar Incisor Hypomineralisation, run by Tanta University at 1 site in Egypt.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Fluoride Varnishes, Molar Incisor Hypomineralisation, Permanent Anterior Teeth
- What is being tested?
- Nanohydroxyapatite Varnish Application and Sodium Fluoride Varnish Application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child had one or more MIH-affected permanent incisors exhibiting a non-cavitated initial carious lesion on the labial surface.
- Lesions with a score of 1 or 2 according to the International Caries Detection and Assessment System (ICDAS).
- Healthy children without any systemic disease.
Who cannot join
- Severely decayed, fractured, or restored MIH-affected teeth that can't be evaluated for varnish effects.
- Presence of orthodontic appliances.
- Developmental defects of enamel other than MIH (Amelogenesis imperfecta, dentinogenesis imperfecta, erosion, dental fluorosis).
- Uncooperative patient and parent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nouran Mohsen Elsayed Basiouny, master contact
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry, Tanta university
Tanta
shaimaa eldesouky, assistant professor, 01008994242, shaimaaeldesouky@dent.tanta.edu.eg
About this study
Official title: Comparative Evaluation of Nanohydroxyapatite and Sodium Fluoride Varnishes in Remineralizing MIH-Affected Young Permanent Anterior Teeth
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).
Read the detailed description
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.
- Conditions
- Fluoride Varnishes, Molar Incisor Hypomineralisation, Permanent Anterior Teeth, Remineralization
- Being tested
- Nanohydroxyapatite Varnish Application, Sodium Fluoride Varnish Application
- Keywords
- Nanohydroxyapatite, Sodium Fluoride Varnishes, Permanent Anterior Teeth, Molar Incisor Hypomineralisation
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanohydroxyapatite Varnish ApplicationProcedure or surgery
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.
Sodium Fluoride Varnish ApplicationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| group-1: Nano-Hydroxyapatite Varnish | Experimental | Young permanent incisors with non-cavitated MIH enamel lesions (ICDAS 1 or 2) treated with 8.6% nanohydroxyapatite varnish. Receives: Procedure: Nanohydroxyapatite Varnish Application |
| Group-2: Sodium Fluoride Varnish | Active comparator | Young permanent incisors with non-cavitated MIH enamel lesions (ICDAS 1 or 2) treated with 5% sodium fluoride varnish. Receives: Procedure: Sodium Fluoride Varnish Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-application), 1 month, 3 months, and 6 months post-application.
Secondary outcomes (1)
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.
Measured: Baseline (pre-application), 1 month, 3 months, and 6 months post-application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start3 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fluoride VarnishesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894510
- Sponsor's protocol ID
- #PED-12-25-3501
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amaechi BT, Tan AI, Noureldin AAK, Kanthaiah K, Holladay E, Obiefuna AC, Vijayaraghavan M. In vitro evaluation of the ability of nanohydroxyapatite toothpastes to enhance remineralization of enamel caries lesion. J Dent. 2025 Oct;161:106006. doi: 10.1016/j.jdent.2025.106006. Epub 2025 Jul 29.
PubMed 40744295Hamed S, Abd El Latief MH, El-Wassefy NA, Montasser MA. Fluoride-amorphous calcium phosphate and biomimetic nano-hydroxyapatite for enamel remineralization: An in-vitro study of surface microhardness and composition. Int Orthod. 2024 Jun;22(2):100865. doi: 10.1016/j.ortho.2024.100865. Epub 2024 Mar 7.
PubMed 38457899
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Nanohydroxyapatite and Sodium Fluoride Varnishes in Remineralizing MIH-Affected Young Permanent Anterior Teeth
- ClinicalTrials.gov ID
- NCT07894510
- Acronym / sponsor ID
- #PED-12-25-3501
- Conditions
- Fluoride Varnishes, Molar Incisor Hypomineralisation, Permanent Anterior Teeth, Remineralization
- Keywords
- Nanohydroxyapatite, Sodium Fluoride Varnishes, Permanent Anterior Teeth, Molar Incisor Hypomineralisation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group-1: Nano-Hydroxyapatite Varnish | Experimental | Procedure: Nanohydroxyapatite Varnish ApplicationYoung permanent incisors with non-cavitated MIH enamel lesions (ICDAS 1 or 2) treated with 8.6% nanohydroxyapatite varnish. |
| Group-2: Sodium Fluoride Varnish | Active comparator | Procedure: Sodium Fluoride Varnish ApplicationYoung permanent incisors with non-cavitated MIH enamel lesions (ICDAS 1 or 2) treated with 5% sodium fluoride varnish. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child had one or more MIH-affected permanent incisors exhibiting a non-cavitated initial carious lesion on the labial surface.
- Lesions with a score of 1 or 2 according to the International Caries Detection and Assessment System (ICDAS).
- Healthy children without any systemic disease.
Key exclusion criteria (4 listed)
- Severely decayed, fractured, or restored MIH-affected teeth that can't be evaluated for varnish effects.
- Presence of orthodontic appliances.
- Developmental defects of enamel other than MIH (Amelogenesis imperfecta, dentinogenesis imperfecta, erosion, dental fluorosis).
- Uncooperative patient and parent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanohydroxyapatite Varnish ApplicationPreparation: 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. | Procedure or surgery | group-1: Nano-Hydroxyapatite Varnish |
| Sodium Fluoride Varnish ApplicationPreparation: 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. | Procedure or surgery | Group-2: Sodium Fluoride Varnish |
Primary outcome
Quantitative Enamel Remineralization / Laser Fluorescence (DIAGNOdent Score)
Time frame: Baseline (pre-application), 1 month, 3 months, and 6 months post-application.
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.
1 secondary outcome
Visual Caries Lesion Severity (ICDAS Score)
Time frame: Baseline (pre-application), 1 month, 3 months, and 6 months post-application.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Results publication: PubMed 40744295Amaechi BT, Tan AI, Noureldin AAK, Kanthaiah K, Holladay E, Obiefuna AC, Vijayaraghavan M. In vitro evaluation of the ability of nanohydroxyapatite toothpastes to enhance remineralization of enamel caries lesion. J Dent. 2025 Oct;161:106006. doi: 10.1016/j.jdent.2025.106006. Epub 2025 Jul 29.
- Results publication: PubMed 38457899Hamed S, Abd El Latief MH, El-Wassefy NA, Montasser MA. Fluoride-amorphous calcium phosphate and biomimetic nano-hydroxyapatite for enamel remineralization: An in-vitro study of surface microhardness and composition. Int Orthod. 2024 Jun;22(2):100865. doi: 10.1016/j.ortho.2024.100865. Epub 2024 Mar 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nouran Mohsen Elsayed Basiouny, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanohydroxyapatite Varnish Application and Sodium Fluoride Varnish Application in people with Fluoride Varnishes and Molar Incisor Hypomineralisation, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa eldesouky, assistant professor (01008994242, shaimaaeldesouky@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Enamel Remineralization / Laser Fluorescence (DIAGNOdent Score) (time frame: Baseline (pre-application), 1 month, 3 months, and 6 months post-application.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07894510, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.