Molar Incisor HypomineralizationPhase 1NCT06515548
Assessment of the Remineralization Efficacy of Vitamin D in the Treatment of MIH. In Vitro Study and In Situ Randomized Double-Blind Placebo Clinical Trial.
A Phase 1 study testing Vitamin D3 mouth wash in people with Molar Incisor Hypomineralization, run by Cairo University at 1 site in Egypt.
Trial summary
In child patients with molar incisor hypo mineralization, Will Vitamin D mouth wash offer more success for patients with MIH as regards better MIH TNI index, decrease plaque accumulation, more gingival health and less bleeding on probing differentiated from placebo mouthwash? Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Vitamin D3 mouth wash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2024to 30 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child
Who may be able to join
- More than 6 years' child with all permanent incisors and first molar teeth are fully erupted with all surfaces visible.
- At least one affected first permanent molar were considered to have MIH (Lygidakis et al. 2010; Kühnisch et al. 2014).
- No chronic systemic disease
- No acute infection
- cooperative Child
Who cannot join
- Drugs (chlorhexidine-based gels and mouthwashes)
- Hypomineralization with a diameter less than 1 mm.
- Hypoplastic defects, fluorosis (diffuse hypomineralization), amelogenesis imperfecta, and dentinogenesis imperfecta.
- Defects on approximal surfaces and diffuse opacities.
- Fixed orthodontic treatment
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Remineralization Efficacy of Vitamin D in the Treatment of Molar Incisor Hypomineralization. In Vitro Study and In Situ Randomized Double-Blind Placebo Controlled Clinical Trial.
In child patients with molar incisor hypo mineralization, Will Vitamin D mouth wash offer more success for patients with MIH as regards better MIH TNI index, decrease plaque accumulation, more gingival health and less bleeding on probing differentiated from placebo mouthwash?
Read the detailed description
Molar incisor hypomineralization (MIH) refers to specific developmental qualitative defect of the enamel that typically affect 1 to all 4 of the permanent molars and can also involve the permanent incisors.
MIH is clinically characterized by morphological enamel defects that can be seen on the occlusal surface of permanent molars and the incisal one-third (or more) of the incisors result from hypomineralization. These defects more or less well-defined opacities that vary in size and can be discoloured from white to yellow brownish. The hypomineralized enamel is friable and has inferior mechanical properties as well as reduced modulus of elasticity when compared to sound enamel.
As a consequence, hypomineralized enamel leads to post-eruptive breakdown and hypersensitivity, and it is prone to development of carious lesions and pain. Due to pain, fragile enamel and increased treatment need at an early point of time in life, MIH treatment represents a clinical challenge. The well-defined opacities are focal subsurface decalcifications in enamel are commonly associated with extended plaque retention. Periodontal disease in children is mainly limited to gingival inflammation and is observed as gingival oedema, colour and contour changes, bleeding on probe or spontaneous bleeding.
Recent study showed that plaque accumulation and gingival inflammation were higher in patients with MIH compared with healthy children, and that oral hygiene and gingival health worsened as the severity of MIH increased.
Vitamin D, plays a pivotal role in many biological functions such as in innate immunity effect, the regulation of calcium (Ca+) and phosphate metabolism and their deposition in mineralized tissues. Since the presence of Vitamin D3 receptors on ameloblast and odontoblast cells, its function in tooth development and remineralization, changes in the biochemical composition of saliva and immunological modulation of dental infection has been suggested.
Vitamin D has been demonstrated to have significant potential in improving the remineralization of early lesions on enamel surfaces enhancing surface microhardness and minerals content. Remineralization is defined as the process whereby calcium and phosphate ions are supplied from a source external to the tooth to promote ion deposiption into crystal voids in demineralized enamel, to produce net mineral gain.
Recent ex-vivo study revealed that the topical application of fluoride and vitamin D promoted the formation of persistent mineral crystals on enamel surfaces of deciduous teeth. Consequently, this study recommends further evaluation to be potentially used as an alternative strategy.
The treatment of teeth affected by MIH should be a minimally invasive procedure that aims to protect, strengthen and preserve dental structure. Numerous therapeutic alternatives have been proposed over time for the treatment of MIH-affected teeth, but the clinical management of these conditions is very demanding and less conservative.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Vitamin D3 mouth wash
- Keywords
- vitamin D, MIH, vitamin D mouth rinse, Molar Incisor Hypomineralization, vitamin D mouthwash, Topical vitamin D
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 mouth washDrug
Also called Vitamin D3 mouth rinse
topical vitamin D oral mouth wash as every 10ml of the solution contains 3000 IU
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D mouthwash | Active comparator | a Receives: Drug: Vitamin D3 mouth wash |
| Placebo mouth wash | Placebo comparator | Not described Receives: Drug: Vitamin D3 mouth wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
MIH TNI
Measured: 3 months
Gingival Index
Measured: 3 months
Plaque Index
Measured: 3 months
Secondary outcomes (1)
Bleeding on Probing
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start30 Aug 2024
- Primary completion1 Feb 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In vitro study and in situ Randomized Double-Blind Placebo controlled Clinical Trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- MTI University
- Responsible party
- Principal investigator, Parryhan Mohamed Abdelsamie, MTI University
- Investigators
- Parryhan M Abdelsamie, PhD, Principal investigator, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515548
- Sponsor's protocol ID
- PMTIU
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2024
- Last updated
- 6 Jul 2026
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Remineralization Efficacy of Vitamin D in the Treatment of Molar Incisor Hypomineralization. In Vitro Study and In Situ Randomized Double-Blind Placebo Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06515548
- Acronym / sponsor ID
- PMTIU
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- vitamin D, MIH, vitamin D mouth rinse, Molar Incisor Hypomineralization, vitamin D mouthwash, Topical vitamin D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- MTI University
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 23 Jul 2024 (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.
In child patients with molar incisor hypo mineralization, Will Vitamin D mouth wash offer more success for patients with MIH as regards better MIH TNI index, decrease plaque accumulation, more gingival health and less bleeding on probing differentiated from placebo mouthwash?
Detailed description
Molar incisor hypomineralization (MIH) refers to specific developmental qualitative defect of the enamel that typically affect 1 to all 4 of the permanent molars and can also involve the permanent incisors.
MIH is clinically characterized by morphological enamel defects that can be seen on the occlusal surface of permanent molars and the incisal one-third (or more) of the incisors result from hypomineralization. These defects more or less well-defined opacities that vary in size and can be discoloured from white to yellow brownish. The hypomineralized enamel is friable and has inferior mechanical properties as well as reduced modulus of elasticity when compared to sound enamel.
As a consequence, hypomineralized enamel leads to post-eruptive breakdown and hypersensitivity, and it is prone to development of carious lesions and pain. Due to pain, fragile enamel and increased treatment need at an early point of time in life, MIH treatment represents a clinical challenge. The well-defined opacities are focal subsurface decalcifications in enamel are commonly associated with extended plaque retention. Periodontal disease in children is mainly limited to gingival inflammation and is observed as gingival oedema, colour and contour changes, bleeding on probe or spontaneous bleeding.
Recent study showed that plaque accumulation and gingival inflammation were higher in patients with MIH compared with healthy children, and that oral hygiene and gingival health worsened as the severity of MIH increased.
Vitamin D, plays a pivotal role in many biological functions such as in innate immunity effect, the regulation of calcium (Ca+) and phosphate metabolism and their deposition in mineralized tissues. Since the presence of Vitamin D3 receptors on ameloblast and odontoblast cells, its function in tooth development and remineralization, changes in the biochemical composition of saliva and immunological modulation of dental infection has been suggested.
Vitamin D has been demonstrated to have significant potential in improving the remineralization of early lesions on enamel surfaces enhancing surface microhardness and minerals content. Remineralization is defined as the process whereby calcium and phosphate ions are supplied from a source external to the tooth to promote ion deposiption into crystal voids in demineralized enamel, to produce net mineral gain.
Recent ex-vivo study revealed that the topical application of fluoride and vitamin D promoted the formation of persistent mineral crystals on enamel surfaces of deciduous teeth. Consequently, this study recommends further evaluation to be potentially used as an alternative strategy.
The treatment of teeth affected by MIH should be a minimally invasive procedure that aims to protect, strengthen and preserve dental structure. Numerous therapeutic alternatives have been proposed over time for the treatment of MIH-affected teeth, but the clinical management of these conditions is very demanding and less conservative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In vitro study and in situ Randomized Double-Blind Placebo controlled Clinical Trial.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D mouthwash | Active comparator | Drug: Vitamin D3 mouth washa |
| Placebo mouth wash | Placebo comparator | Drug: Vitamin D3 mouth wash |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- More than 6 years' child with all permanent incisors and first molar teeth are fully erupted with all surfaces visible.
- At least one affected first permanent molar were considered to have MIH (Lygidakis et al. 2010; Kühnisch et al. 2014).
- No chronic systemic disease
- No acute infection
- cooperative Child
Key exclusion criteria (6 listed)
- Drugs (chlorhexidine-based gels and mouthwashes)
- Hypomineralization with a diameter less than 1 mm.
- Hypoplastic defects, fluorosis (diffuse hypomineralization), amelogenesis imperfecta, and dentinogenesis imperfecta.
- Defects on approximal surfaces and diffuse opacities.
- Fixed orthodontic treatment
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 |
|---|---|---|
| Vitamin D3 mouth washAlso: Vitamin D3 mouth rinsetopical vitamin D oral mouth wash as every 10ml of the solution contains 3000 IU | Drug | Placebo mouth wash, Vitamin D mouthwash |
Primary outcome
MIH TNI
Time frame: 3 months
Gingival Index
Time frame: 3 months
Plaque Index
Time frame: 3 months
1 secondary outcome
Bleeding on Probing
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 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. This study is not recruiting at the moment.
Parryhan M Abdelsamie, PhD principal investigator
MTI University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D3 mouth wash in people with Molar Incisor Hypomineralization, run by Cairo 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 6 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MIH TNI (time frame: 3 months). The study lists 3 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 6 Jul 2026.