Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH): A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Sealant retention
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Resin-based fissure sealant
Resin-based fissure sealant is applied after etching with phosphoric acid
Intervention: Conventional Resin-based Sealant (Procedure)
Pre-etched Bioactive Sealant
Bioactive fissure sealant applied after etching with phosphoric acid
Intervention: Pre-etched Bioactive Sealant (Procedure)
Outcomes
Primary Outcomes
Sealant retention
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 3,6 and 12 months
Evaluation of anatomic form using the modified United States of Public Health Service Criteria.
Surface Texture
Time Frame: 3,6 and 12 months
Evaluation for surface texture using the modified United States of Public Health Service Criteria
Secondary Outcomes
- Sensitivity(Pre-operative, 3,6, and 12 months)