Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Molar Incisor Hypomineralization (MIH) is enamel hypomineralization defined as qualitative defects caused by disruptions in either the calcification or maturation phases of amelogenesis affecting one or more first permanent molars (FPMs) and permanent incisors.
Conventional treatment for such defects necessitates additional removal of the complete tooth structure to receive full crowns that cause more biologically harmful consequences like postoperative hypersensitivity and aggressive tooth structure loss. To fulfill the biological criteria for tooth preparation, conservatism is the major notion and goal that prosthodontists strive to achieve. Nowadays, minimally invasive techniques are frequently employed to support this idea. To meet the growing need for conservative and attractive tooth restorations, overlay ceramic restorations (covering all cusps) are becoming more necessary. These restorations show satisfactory mechanics, restoring function, and esthetic with preserving tooth structure Since all materials used to treat such cases, have distinct chemical compositions, they have different properties that affect their clinical outcome. Therefore, it is essential to compare them clinically because any restoration's clinical outcome affects its long-term success. According to the null hypothesis, different materials would not significantly affect the clinical result of ceramic overlay restorations.
Patients in all groups will receive a minimally invasive restoration with high esthetic advantages (Protection of the weak cusps and elimination of carious lesions with an esthetic way out) and long-term success of their MIH affected young permanent molars (either IPS e.max CAD, Direct nanohybrid flowable composite or VITA Suprinity PC-Glass ceramic (zirconia) that require minimal preparation depends on the type of restoration will receive.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct nanohybrid flowable composite | Active Comparator | is a bioactive flowable nano-hybrid restorative with a newly developed patented nanofiller. It is indicated for all classes including occlusal and cusp. It has all of the Giomer Technology attributes, anti-bacterial, acid neutralization, and fluoride release and recharge, with improved handling and effortless polishing, and maintains a long-lasting shine. Beautifil Flow Plus X has the strength, durability, and aesthetics of a hybrid composite |
|
| IPS e.max CAD | Experimental | glass-ceramic-based restorations still offer the best translucency and esthetic qualities. The novel generation of lithium disilicate-based materials as IPS e.max CAD provides standard thickness and quick fabrication. Moreover, the adhesive technique used with this restoration type significantly raises its mechanical properties |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| restoring the MIH affected young permanent molars using Direct nanohybrid flowable composite | Other | (Shofu)is a bioactive flowable nano-hybrid restorative with a newly developed patented nanofiller. It is indicated for all classes including occlusal and cusp. It has all of the Giomer Technology attributes, anti-bacterial, acid neutralization, and fluoride release and recharge, with improved handling and effortless polishing, and maintains a long-lasting shine. Beautifil Flow Plus X has the strength, durability, and aesthetics of a hybrid composite. |
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetic Clinical success | According to FDI World Dental Federation criteria Five subcategories. From best to worst, the subcategories were: (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable, and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure. | 12 months (baseline ''1 day '', 6 and 12 months) |
| Functional Clinical success | According to FDI World Dental Federation criteria Five subcategories. From best to worst, the subcategories were: (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable, and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure. | 12 months (baseline ''1 day '', 6 and 12 months) |
| Biological clinical success | According to FDI World Dental Federation criteria Five subcategories. From best to worst, the subcategories were: (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable, and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure. | 12 months (baseline ''1 day '', 6 and 12 months) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud M. Attia, Ph.D | Lecturer of Fixed Prosthodontics MSA University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MSA University | El-Sheikh Zayed City | Giza Governorate | 16672 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 1, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| restoring the MIH affected young permanent molars using IPS e.max CAD | Other | glass-ceramic-based restorations still offer the best translucency and esthetic qualities. The novel generation of lithium disilicate-based materials as IPS e.max CAD provides standard thickness and quick fabrication. Moreover, the adhesive technique used with this restoration type significantly raises its mechanical properties. |
|
| Jun 24, 2025 |
| Prot_SAP_ICF_000.pdf |
| 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 |
Not provided
Not provided