Resin Infiltrate As Pit and Fissure Sealant in Permanent Molars

Tanta University

Status and phase: Not yet enrolling; Phase 4

Conditions: Pit and Fissure Sealant; Permanent Molars; Resin Infiltration

Treatments: Drug: Resin-based fissure sealant in vitro; Drug: ICON resin infiltration Material group in vivo; Drug: Resin-based fissure sealant group in vivo; Drug: ICON resin infiltration in vitro

Study type: Interventional

Funder types: Other

Identifiers

NCT06729788

Resin Infiltrate

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age of the children from 6 to 8 years.
2. Healthy children free from any systemic disease.
3. Show bilaterally sound fully erupted lower first permanent molars with deep narrow central fissures and supplemental grooves.
4. The eruption time of these molars should not exceed 3 years.
5. No sign of pain or active periodontal disease in the selected teeth.

Exclusion criteria

1. Children with fillings or sealants in the selected teeth.
2. Children with clinical evidence of caries in the selected teeth either white spot lesions or cavities.
3. Children with an allergy to any drug, such as resin restorative material.
4. Children with Extremely poor oral hygiene.
5. Hypoplastic teeth.
6. Children with bruxism.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 4 patient groups, including a placebo group

ICON resin infiltration group (in vivo)

Experimental group

Description:

The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK)

Treatment:

Drug: ICON resin infiltration Material group in vivo

Resin-based fissure sealant group (in vivo)

Placebo Comparator group

Description:

The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)

Treatment:

Drug: Resin-based fissure sealant group in vivo

ICON resin infiltration Material (in vitro)

Experimental group

Description:

The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK)

Treatment:

Drug: ICON resin infiltration in vitro

Resin-based fissure sealant (in vitro)

Placebo Comparator group

Description:

The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)\*\*

Treatment:

Drug: Resin-based fissure sealant in vitro