Fissure Sealant, Molar Incisor Hypomineralization
Conditions
Keywords
Molar Incisor Hypomineralization, Fissure sealant, Children, Bioactive Dental material
Brief summary
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.
Detailed description
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).
Interventions
PROCEDUREPre-etched Bioactive Sealant
Application of the bioactive sealant after etching, washing, drying, and primer use.
PROCEDUREConventional Resin-based Sealant
Application of resin-based fissure sealant after etching, washing, drying and bonding.
Sponsors
Jordan University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* 6-12-year-old patients with at least one fully erupted first permanent molar (FPM) diagnosed with MIH defects (White, creamy, or yellow to brownish opacities greater than one millimetre) without posteruptive enamel breakdown or caries (ICDAS code 0 or 1). * Non -contributory medical history * Children must exhibit sufficient cooperation for treatment. * FPMs status of eruption must allow for proper isolation.
Exclusion criteria
- * Medically compromised patient.- Partially erupted MIH first permanent molars that could not be sufficiently isolated. * Carious molars. * Restored MIH molars. * Sealed MIH molars. * MIH molars with extensive enamel breakdown that requires restoration. * MIH molars planned for extraction (compensatory or balancing extraction) as part of elective extraction plan of MIH molars with poor long-term prognosis. * Molars affected with other enamel defects ((e.g., amelogenesis imperfecta or fluorosis) * Non-MIH affected molars. * Parents did not consent for treatment. * Child not sufficiently cooperative for treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sealant retention | 3,6 and 12 months | 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 |
| Marginal integrity | 3,6 and 12 months | 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. |
| Marginal discoloration | 3,6 and 12 months | Evaluation for marginal discolouration using the Modified United States Public Health Service (USPHS) criteria under good light source and using a dental mirror |
| Secondary Caries | 3,6 and 12 months | 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. |
| Anatomic form | 3,6 and 12 months | Evaluation of anatomic form using the modified United States of Public Health Service Criteria. |
| Surface Texture | 3,6 and 12 months | Evaluation for surface texture using the modified United States of Public Health Service Criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Pre-operative, 3,6, and 12 months | Evaluation of pre-operative and post-operative sensitivity using the Schiff Cold Air Sensitivity Scale (SCASS). |
Countries
Jordan
Outcome results
None listed