NCT06729788

Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars

Evaluation of Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars (In Vivo& In Vitro)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate and compare the clinical effectiveness of ICON resin Infiltration versus conventional sealant and the microleakage and penetration depth of the two sealant materials.

Detailed description

Using the resin infiltration technique as a different approach for sealing pits and fissures creates a diffusion barrier as resin infiltrate tends to inhibit enamel pores that serve as diffusion channels for acids and dissolved minerals within the lesion body. A low-viscosity resin that can penetrate into caries lesions, which is referred to as resin infiltration technique. The mechanisms associated with this method depend on the infiltration of subsurface lesions with low-viscosity light-curing resins after eroding the highly mineralized surface layer and increasing penetration depth. This method is believed to overcome the limitations of sealant applications and is considered to be a better alternative for the treatment of initial caries lesions.

Conditions

• Resin Infiltration
• Pit and Fissure Sealant
• Permanent Molars

Interventions

Type	Name	Description
DRUG	ICON resin infiltration Material group in vivo	The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK).
DRUG	Resin-based fissure sealant group in vivo	The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)
DRUG	ICON resin infiltration in vitro	The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) in vitro
DRUG	Resin-based fissure sealant in vitro	The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael) in vitro

Timeline

• Start date: 2025-01-04
• Primary completion: 2025-11-15
• Completion: 2025-12-24
• First posted: 2024-12-11
• Last updated: 2024-12-11

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study