Molar-Incisor Hypomineralization (MIH)NCT07436039
Color Change and Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste
A study testing Fluoridated Toothpaste and Nano-hydroxyapatite Toothpaste in people with Molar-Incisor Hypomineralization (MIH), run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
This clinical trial aims to evaluate if nano-hydroxyapatite (Nano-HA) toothpaste effectively treats children with Molar-Incisor Hypomineralization (MIH). It will also assess the safety of Nano-HA toothpaste. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Molar-Incisor Hypomineralization (MIH)
- What is being tested?
- Fluoridated Toothpaste and Nano-hydroxyapatite Toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Oct 2025to 1 Jul 2027
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-12 years.
- Diagnosed with Molar-Incisor Hypomineralization (MIH) in at least one first permanent molar or hypomineralization of a second primary molar (HSPM).
- Presence of white, creamy, yellow, or brown demarcated opacities
- Indexed teeth include permanent first molars and permanent maxillary incisors.
Who cannot join
- • Decayed permanent molars.
- Diabetes, hypertension, sleeping disorders, or allergic reactions to medications.
- Children on medication
- Presence of other enamel defects (e.g., fluorosis, amelogenesis imperfecta, enamel hypoplasia, or white spot lesions).
- Previous treatment with liquid enamel or other remineralizing agents on affected teeth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz University Hospital, Jeddah, Saudi Arabia
Jeddah
About this study
This clinical trial aims to evaluate if nano-hydroxyapatite (Nano-HA) toothpaste effectively treats children with Molar-Incisor Hypomineralization (MIH). It will also assess the safety of Nano-HA toothpaste. The main questions are:
- Does Nano-HA toothpaste reduce caries incidence, improve tooth aesthetics, and decrease hypersensitivity?
- How does Nano-HA compare to fluoridated toothpaste in terms of outcomes?
Read more
Participants will:
- Use Nano-HA or fluoridated toothpaste daily for 12 months.
- Visit the clinic for checkups and evaluations every 1 to 3 months.
- Record symptoms, brushing compliance, and sensitivity.
The study will compare Nano-HA toothpaste to fluoridated toothpaste to determine its efficacy in managing MIH .
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Being tested
- Fluoridated Toothpaste, Nano-hydroxyapatite Toothpaste
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoridated ToothpasteDevice
Participants will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months to compare its effects with Nano-hydroxyapatite.
Nano-hydroxyapatite ToothpasteDevice
Participants in this group will brush their teeth with Nano-hydroxyapatite toothpaste three times daily under parental supervision for 9 months to evaluate its impact on caries reduction, aesthetics, and sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Nano-hydroxyapatite Toothpaste Group | Experimental | Participants in this group will use Nano-hydroxyapatite toothpaste for 9 months to assess its effect on reducing caries, improving aesthetics, and decreasing sensitivity. Receives: Device: Nano-hydroxyapatite Toothpaste |
| Fluoridated Toothpaste Group | Active comparator | Participants in this group will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months. Receives: Device: Fluoridated Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste
Hypersensitivity can be measured using the Schiff sensitivity scale to rate patients' pain The Schiff Cold Air Sensitivity Scale is a 4-point scale used to assess dentin hypersensitivity. A score of zero indicates no sensitivity, one signifies mild sensitivity without a request to stop the stimulus, two represents moderate sensitivity with a request to stop or visible discomfort, and three indicates severe sensitivity with a request to stop and physical withdrawal.
Measured: Follow-up duration: 12 months. Clinical evaluations will be conducted at baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5). The primary endpoint will be assessed at 6 months to evaluate treatment effectiveness
Secondary outcomes (1)
Color Change of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste
The VITA Easyshade® advance spectrophotometer (VITA Zahnfabrik, Bad Sackingen, Germany) will be used to assess the color of MIH-affected permanent incisors and the adjacent sound enamel
Measured: 12 months (Evaluations will be conducted at follow-up intervals: 1 month, 3 months, 6 months, 9 months and 12 months after the trial starts).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Oct 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar-Incisor Hypomineralization (MIH)Studies of the same condition, open and under way.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba sabbagh, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436039
- Sponsor's protocol ID
- MIH
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Change and Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste
- ClinicalTrials.gov ID
- NCT07436039
- Acronym / sponsor ID
- MIH
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Feb 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 clinical trial aims to evaluate if nano-hydroxyapatite (Nano-HA) toothpaste effectively treats children with Molar-Incisor Hypomineralization (MIH). It will also assess the safety of Nano-HA toothpaste. The main questions are:
- Does Nano-HA toothpaste reduce caries incidence, improve tooth aesthetics, and decrease hypersensitivity?
- How does Nano-HA compare to fluoridated toothpaste in terms of outcomes?
Participants will:
- Use Nano-HA or fluoridated toothpaste daily for 12 months.
- Visit the clinic for checkups and evaluations every 1 to 3 months.
- Record symptoms, brushing compliance, and sensitivity.
The study will compare Nano-HA toothpaste to fluoridated toothpaste to determine its efficacy in managing MIH .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano-hydroxyapatite Toothpaste Group | Experimental | Device: Nano-hydroxyapatite ToothpasteParticipants in this group will use Nano-hydroxyapatite toothpaste for 9 months to assess its effect on reducing caries, improving aesthetics, and decreasing sensitivity. |
| Fluoridated Toothpaste Group | Active comparator | Device: Fluoridated ToothpasteParticipants in this group will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-12 years.
- Diagnosed with Molar-Incisor Hypomineralization (MIH) in at least one first permanent molar or hypomineralization of a second primary molar (HSPM).
- Presence of white, creamy, yellow, or brown demarcated opacities
- Indexed teeth include permanent first molars and permanent maxillary incisors.
Key exclusion criteria (5 listed)
- • Decayed permanent molars.
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 |
|---|---|---|
| Fluoridated ToothpasteParticipants will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months to compare its effects with Nano-hydroxyapatite. | Device | Fluoridated Toothpaste Group |
| Nano-hydroxyapatite ToothpasteParticipants in this group will brush their teeth with Nano-hydroxyapatite toothpaste three times daily under parental supervision for 9 months to evaluate its impact on caries reduction, aesthetics, and sensitivity. | Device | Nano-hydroxyapatite Toothpaste Group |
Primary outcome
Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste
Time frame: Follow-up duration: 12 months. Clinical evaluations will be conducted at baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5). The primary endpoint will be assessed at 6 months to evaluate treatment effectiveness
Hypersensitivity can be measured using the Schiff sensitivity scale to rate patients' pain The Schiff Cold Air Sensitivity Scale is a 4-point scale used to assess dentin hypersensitivity. A score of zero indicates no sensitivity, one signifies mild sensitivity without a request to stop the stimulus, two represents moderate sensitivity with a request to stop or visible discomfort, and three indicates severe sensitivity with a request to stop and physical withdrawal.
1 secondary outcome
Color Change of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste
Time frame: 12 months (Evaluations will be conducted at follow-up intervals: 1 month, 3 months, 6 months, 9 months and 12 months after the trial starts).
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 27 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoridated Toothpaste and Nano-hydroxyapatite Toothpaste in people with Molar-Incisor Hypomineralization (MIH), run by King Abdulaziz University at 1 site in Saudi Arabia.
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 4 inclusion and 5 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 27 Feb 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 Saudi Arabia. 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 sabbagh (+966 50 566 8481, hjsabbagh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste (time frame: Follow-up duration: 12 months. Clinical evaluations will be conducted at baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5). The primary endpoint will be assessed at 6 months to evaluate treatment effectiveness). 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 27 Feb 2026.