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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8.6% nano-hydroxy apatite crystals varnish. | Experimental | Intervention group (1) |
|
| Potassium Nitrate gel | Experimental | Intervention group (2) |
|
| 5% fluoride varnish | Active Comparator | Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nano hydroxy apatite varnish | Drug | Intervention (1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dentin Hypersensitivity | Measured by: Face scale: scores from 0-4. the higher the score the worse the sensitivity. | 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. | Baseline, 15 miutes pot-op, 2 weeks post-op, and 4 weeks post op. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-eruptive enamel breakdown | Measured by Wurzburg Molar Incisor Hypomineralization - Treatment Need Index (MIH-TNI): ordinal scores: 1,2,3, 4a, 4b, 4c. | : baseline, 3-, 6-, 9-, and 12- month post-op. |
| Caries incidence |
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The research unit of this study will be the MIH-affected permanent tooth, in children aged from six to ten years, from either gender.
Inclusion criteria:
Participants related criteria:
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).
Participants related criteria:
Tooth related criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mennat Allah AA Abd Elsabour, PhD student | Contact | +201026022605 | mennatallah.ashraf@dentistry.cu.edu.eg |
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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 |
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| ID | Term |
|---|---|
| D005460 | Fluorides, Topical |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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the assessment of outcomes will be performed with two investigators other than the main investigator, who will not be aware of the type of the intervention carried out on the assessed child.
| Potassium Nitrate Gel | Drug | Intervention (2) |
|
|
| Varnishes, Fluoride | Drug | Control |
|
|
Measured by International Caries Detection and Assessment System (ICDAS II) criteria: scores from 0-6.
The higher the score the worse the caries.
| baseline, 3-, 6-, 9-, and 12- month post-op. |
| Oral hygiene | Measured by Plaque Control Record: Percentage. | 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. | 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 | 12-month- post-op. |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002327 |
| Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |