Molar Incisor HypomineralisationNCT06896565
Effect of Nano Hydroxy Apatite Varnish and Potassium Nitrate Gel on the MIH-affected Permanent Teeth
A study testing nano hydroxy apatite varnish, Potassium Nitrate Gel and Varnishes, Fluoride in people with Molar Incisor Hypomineralisation, run by Cairo University.
Trial summary
This clinical study main goal is to investigate the effectiveness of nano hydroxy apatite crystal varnish and potassium nitrate gel as a non invasive approach in managing MIH-affected teeth. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Molar Incisor Hypomineralisation
- What is being tested?
- nano hydroxy apatite varnish, Potassium Nitrate Gel and Varnishes, Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Aug 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants related criteria:
- Children aged from six to ten years old.
- Medically free children according to the history taken from their parents.
- Children who are categorized as Class I or II according to the American Society of Anaesthesiologists (ASA).
- Children whom their parents accept to comply with the follow-up visits.
- Children who accept, and their guardians, to participate in the study by signing the informed consent.
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- Children with no more than four cavitated primary teeth.
- Tooth related criteria:
- 1. The diagnosis of MIH will be done as per the Wurzburg concept, 2023 MIH diagnostic criteria:
- The child will be confirmed to have MIH if any of the following characteristics are apparent:
- affected teeth show a clearly defined opacity at the occlusal and buccal surfaces of a tooth,
- defects vary in shape, size, and pattern,
- white, cream-colored, or yellow-brown color deviations are recognizable,
- defects variably vary in size,
- teeth with hypersensitivity are present,
- teeth have an atypical restoration,
- permanent teeth for (suspected) MIH reasons are missing (extractions),
- combinations of the above characteristics are present.
- MIH-affected permanent teeth, suffering from dentin hypersensitivity, (MIH-TNI 3, 4a).
- Positive Schiff Cold Airblasting Sensitivity score (score 1, 2, or 3).
Who cannot join
- Participants related criteria:
- Children with severe behavioral or emotional disabilities.
- Children who received analgesics within the last 24 hours before the procedure.15
- Patients who are using chlorhexidine-based gels or mouthwashes.
- Tooth related criteria:
- A tooth with signs and symptoms of irreversible pulpitis.
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- A tooth with signs and symptoms of necrotic pulp.
- Sealing therapy or application of desensitizing agent on the MIH teeth within one month before participation in the study.
- Presence of dental caries on the MIH-affected permanent tooth.
- Presence of restoration(s) on MIH-affected permanent tooth.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mennat Allah AA Abd Elsabour, PhD student contact
About this study
Official title: Comparative Evaluation of Three Different Topically Applied Materials as Non-invasive Treatment of Permanent Teeth With Molar Incisor Hypo-mineralization: Randomized Clinical Trial
This clinical study main goal is to investigate the effectiveness of nano hydroxy apatite crystal varnish and potassium nitrate gel as a non invasive approach in managing MIH-affected teeth.
Read the detailed description
This randomized clinical trial study aims to investigate the effectiveness of nano-hydroxy apatite crystal varnish, and potassium nitrate gel compared to fluoride varnish, in reducing dentin hypersensitivity, improving a child's oral hygiene, and gingival health, oral health-related quality of life, preventing post-eruptive enamel breakdown, and dental caries, along with economic evaluation.
- Conditions
- Molar Incisor Hypomineralisation
- Being tested
- nano hydroxy apatite varnish, Potassium Nitrate Gel, Varnishes, Fluoride
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nano hydroxy apatite varnishDrug
Also called Fygg's professional strength, Fygg, USA
Intervention (1)
Potassium Nitrate GelDrug
Also called Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USA
Intervention (2)
Varnishes, FluorideDrug
Also called DentKist Charm Varnish 5% Sodium Fluoride Varnish
Control
| Study group | Role | What they receive |
|---|---|---|
| 8.6% nano-hydroxy apatite crystals varnish. | Experimental | Intervention group (1) Receives: Drug: nano hydroxy apatite varnish |
| Potassium Nitrate gel | Experimental | Intervention group (2) Receives: Drug: Potassium Nitrate Gel |
| 5% fluoride varnish | Active comparator | Control group Receives: Drug: Varnishes, Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentin Hypersensitivity
Measured by:
Face scale: scores from 0-4. the higher the score the worse the sensitivity.
Measured: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.
Dentin Hypersensitivity
Measured by:
Schiff Cold Air Blasting Sensitivity Scale: scores from 0-3. The higher the score the worse the sensitivity.
Measured: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.
Secondary outcomes (5)
Post-eruptive enamel breakdown
Measured by Wurzburg Molar Incisor Hypomineralization - Treatment Need Index (MIH-TNI): ordinal scores: 1,2,3, 4a, 4b, 4c.
Measured: : baseline, 3-, 6-, 9-, and 12- month post-op.
Caries incidence
Measured by International Caries Detection and Assessment System (ICDAS II) criteria: scores from 0-6.
The higher the score the worse the caries.
Measured: baseline, 3-, 6-, 9-, and 12- month post-op.
Oral hygiene
Measured by Plaque Control Record: Percentage.
Measured: baseline, 2-, and 4- week post-op.
Oral health-related quality of life
Measured by: Short form Parental-Caregiver Perceptions Questionnaire (P-CPQ): from 0 -32.
The higher the score the worse the Oral Health Related Quality of Life.
Measured: baseline, 6-, and 12- month post-op.
Cost Effectiveness Ratio (CER) and Incremental Cost Effectiveness Ratio (ICER
Measured by: Equation : CER = C / E, where C is the average direct medical cost calculated for the group, and E is the health effectiveness measure for the same group (change in hypersensitivity score).
ICER = (CI - CC) / (EI - EC), where CI is the average direct medical cost of the intervention group CC is the average direct medical cost in the control group, EI is the health effectiveness measure (change in hypersensitivity score) in the intervention group, and EC is the health effectiveness measure in the control group
Measured: 12-month- post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion20 Aug 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralisationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Ashraf Abd Elsabour Abd Elkareem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896565
- Sponsor's protocol ID
- 22222
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Three Different Topically Applied Materials as Non-invasive Treatment of Permanent Teeth With Molar Incisor Hypo-mineralization: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06896565
- Acronym / sponsor ID
- 22222
- Conditions
- Molar Incisor Hypomineralisation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 26 Mar 2025 (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 clinical study main goal is to investigate the effectiveness of nano hydroxy apatite crystal varnish and potassium nitrate gel as a non invasive approach in managing MIH-affected teeth.
Detailed description
This randomized clinical trial study aims to investigate the effectiveness of nano-hydroxy apatite crystal varnish, and potassium nitrate gel compared to fluoride varnish, in reducing dentin hypersensitivity, improving a child's oral hygiene, and gingival health, oral health-related quality of life, preventing post-eruptive enamel breakdown, and dental caries, along with economic evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 8.6% nano-hydroxy apatite crystals varnish. | Experimental | Drug: nano hydroxy apatite varnishIntervention group (1) |
| Potassium Nitrate gel | Experimental | Drug: Potassium Nitrate GelIntervention group (2) |
| 5% fluoride varnish | Active comparator | Drug: Varnishes, FluorideControl group |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- Children aged from six to ten years old.
- Medically free children according to the history taken from their parents.
- Children who are categorized as Class I or II according to the American Society of Anaesthesiologists (ASA).
- Children whom their parents accept to comply with the follow-up visits.
- Children who accept, and their guardians, to participate in the study by signing the informed consent.
Key exclusion criteria (10 listed)
- Children with severe behavioral or emotional disabilities.
- Children who received analgesics within the last 24 hours before the procedure.15
- Patients who are using chlorhexidine-based gels or mouthwashes.
- A tooth with signs and symptoms of irreversible pulpitis.
- A tooth with signs and symptoms of necrotic pulp.
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 |
|---|---|---|
| nano hydroxy apatite varnishAlso: Fygg's professional strength, Fygg, USAIntervention (1) | Drug | 8.6% nano-hydroxy apatite crystals varnish. |
| Potassium Nitrate GelAlso: Ultradent UltraEZ Desensitizing Gel, Ultradent Inc., USAIntervention (2) | Drug | Potassium Nitrate gel |
| Varnishes, FluorideAlso: DentKist Charm Varnish 5% Sodium Fluoride VarnishControl | Drug | 5% fluoride varnish |
Primary outcome
Dentin Hypersensitivity
Time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.
Measured by: Face scale: scores from 0-4. the higher the score the worse the sensitivity.
Dentin Hypersensitivity
Time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.
Measured by: Schiff Cold Air Blasting Sensitivity Scale: scores from 0-3. The higher the score the worse the sensitivity.
5 secondary outcomes
Post-eruptive enamel breakdown
Time frame: : baseline, 3-, 6-, 9-, and 12- month post-op.
Caries incidence
Time frame: baseline, 3-, 6-, 9-, and 12- month post-op.
Oral hygiene
Time frame: baseline, 2-, and 4- week post-op.
Oral health-related quality of life
Time frame: baseline, 6-, and 12- month post-op.
Cost Effectiveness Ratio (CER) and Incremental Cost Effectiveness Ratio (ICER
Time frame: 12-month- post-op.
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 24 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Mennat Allah AA Abd Elsabour, PhD student contact
Questions about this trial
What is this clinical trial studying?
A study testing nano hydroxy apatite varnish, Potassium Nitrate Gel and Varnishes, Fluoride in people with Molar Incisor Hypomineralisation, run by Cairo University.
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 20 inclusion and 10 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: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Mennat Allah AA Abd Elsabour, PhD student (+201026022605, mennatallah.ashraf@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentin Hypersensitivity (time frame: Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2025.