Color Change and Desensitization of Molar Incisor Hypomineralization-Affected Enamel Using Biomimetic Nano-Hydroxyapatite Toothpaste
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluoridated Toothpaste, Nano-hydroxyapatite Toothpaste.
- Who it may be relevant to
- Registry conditions: Molar-Incisor Hypomineralization (MIH). Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 .
Interventions
- Device Fluoridated Toothpaste
Participants will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months to compare its effects with Nano-hydroxyapatite. - Device Nano-hydroxyapatite Toothpaste
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.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- 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).]
Eligibility criteria
Inclusion criteria
\- 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.
Exclusion criteria
- • 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Saudi Arabia · 1 center
- King Abdulaziz University Hospital, Jeddah, Saudi Arabia — Jeddah
Identifiers
NCT: NCT07436039 · MIH