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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:
Participants will:
The study will compare Nano-HA toothpaste to fluoridated toothpaste to determine its efficacy in managing MIH .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoridated Toothpaste | Device | Participants will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months to compare its effects with Nano-hydroxyapatite. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). |
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Inclusion Criteria:
- Children aged 6-12 years.
Exclusion Criteria:
• Decayed permanent molars.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| sabbagh | Contact | +966 50 566 8481 | hjsabbagh@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz University Hospital, Jeddah, Saudi Arabia | Recruiting | Jeddah | Saudi Arabia |
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| Nano-hydroxyapatite Toothpaste | Device | 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. |
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| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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