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This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity.
Molar Incisor Hypomineralization (MIH) poses a significant clinical challenge in pediatric dentistry due to enamel fragility, hypersensitivity, and increased susceptibility to caries. While conventional resin-based fissure sealant (RBFS) is the gold standard fissure sealant material for occlusal caries, its performance on hypomineralized enamel remains suboptimal. Bioactive sealants are newly developed materials that promote remineralization and utilize both mechanical and chemical adhesion; however, they demonstrate poor retention when used with their self-etching primer. Bioactive sealants with phosphoric acid pre-etching may offer improved clinical outcomes for MIH-affected teeth. This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity. Participants will be randomly allocated to receive either a bioactive sealant with phosphoric acid pre-etching or conventional RBFS. Clinical evaluations will be performed at 3-, 6-, and 12- months post-application using Modified United States Public Health Service (USPHS) criteria to assess retention, marginal adaptation, and secondary caries formation. Pre and postoperative sensitivity will be measured using the Schiff Cold Air Sensitivity Scale (SCASS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-etched Bioactive Sealant | Experimental | Bioactive fissure sealant applied after etching with phosphoric acid |
|
| Resin-based fissure sealant | Active Comparator | Resin-based fissure sealant is applied after etching with phosphoric acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-etched Bioactive Sealant | Procedure | Application of the bioactive sealant after etching, washing, drying, and primer use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sealant retention | Evaluation of sealant retention using the Modified United States Public Health Service (USPHS) criteria under good light source and using a dental mirror and a straight explorer | 3,6 and 12 months |
| Marginal integrity | Evaluation for the presence of fractures or gaps in the sealant-tooth interface using the Modified United States Public Health Service (USPHS) criteria under a good light source and using a dental mirror and straight explorer. | 3,6 and 12 months |
| Marginal discoloration | Evaluation for marginal discolouration using the Modified United States Public Health Service (USPHS) criteria under good light source and using a dental mirror | 3,6 and 12 months |
| Secondary Caries | Evaluation for new caries using the Modified United States Public Health Service (USPHS) criteria under a good light source and using a dental mirror and a straight explorer. | 3,6 and 12 months |
| Anatomic form | Evaluation of anatomic form using the modified United States of Public Health Service Criteria. | 3,6 and 12 months |
| Surface Texture | Evaluation for surface texture using the modified United States of Public Health Service Criteria | 3,6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Evaluation of pre-operative and post-operative sensitivity using the Schiff Cold Air Sensitivity Scale (SCASS). | Pre-operative, 3,6, and 12 months |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University of Science and Technology | Irbid | Jordan |
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| Conventional Resin-based Sealant | Procedure | Application of resin-based fissure sealant after etching, washing, drying and bonding. |
|
| 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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