An interventional study of Pre-etched Bioactive Sealant and Conventional Resin-based Sealant in Molar Incisor Hypomineralization and Fissure Sealant, sponsored by Jordan University of Science and Technology. Enrolling by invitation at 1 site in Jordan. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Jordan University of Science and Technology · Not applicable, Interventional, and Prevention
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).
Inclusion Criteria:
Bioactive fissure sealant applied after etching with phosphoric acid
Procedure: Pre-etched Bioactive Sealant
Resin-based fissure sealant is applied after etching with phosphoric acid
Procedure: Conventional Resin-based Sealant
Application of the bioactive sealant after etching, washing, drying, and primer use.
Application of resin-based fissure sealant after etching, washing, drying and bonding.
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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 3,6 and 12 months
Anatomic form
Evaluation of anatomic form using the modified United States of Public Health Service Criteria.
Time frame: 3,6 and 12 months
Surface Texture
Evaluation for surface texture using the modified United States of Public Health Service Criteria
Time frame: 3,6 and 12 months
Sensitivity
Evaluation of pre-operative and post-operative sensitivity using the Schiff Cold Air Sensitivity Scale (SCASS).
Time frame: Pre-operative, 3,6, and 12 months
Plan to share: Undecided
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Jordan University of Science and Technology