Evaluation of Resin Infiltrate As Pit and Fissure Sealant in Permanent Molars (In Vivo& in Vitro)
Overview
- Phase
- Phase 4
- Intervention
- ICON resin infiltration Material group in vivo
- Conditions
- Resin Infiltration
- Sponsor
- Tanta University
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Salsabeel Mahmoud Abdelgaffar Shalaby
Dentist, Pediatric dentistry, Oral Health and Preventive Dentistry Department
Tanta University
Eligibility Criteria
Inclusion Criteria
- •Age of the children from 6 to 8 years.
- •Healthy children free from any systemic disease.
- •Show bilaterally sound fully erupted lower first permanent molars with deep narrow central fissures and supplemental grooves.
- •The eruption time of these molars should not exceed 3 years.
- •No sign of pain or active periodontal disease in the selected teeth.
Exclusion Criteria
- •Children with fillings or sealants in the selected teeth.
- •Children with clinical evidence of caries in the selected teeth either white spot lesions or cavities.
- •Children with an allergy to any drug, such as resin restorative material.
- •Children with Extremely poor oral hygiene.
- •Hypoplastic teeth.
- •Children with bruxism.
Arms & Interventions
ICON resin infiltration group (in vivo)
The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK)
Intervention: ICON resin infiltration Material group in vivo
Resin-based fissure sealant group (in vivo)
The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)
Intervention: Resin-based fissure sealant group in vivo
ICON resin infiltration Material (in vitro)
The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK)
Intervention: ICON resin infiltration in vitro
Resin-based fissure sealant (in vitro)
The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)\*\*
Intervention: Resin-based fissure sealant in vitro
Outcomes
Primary Outcomes
Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria.
Time Frame: 3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 months
172 permanent mandibular molars out of 86 children will be randomly allocated into two equal groups. Group 1: The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK). Group 2: The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael).For application of ICON, an ample amount of Icon-Infiltrate is applied into the fissure away from the direct light of the dental unit and let sit for 3 minutes. After excess removal, it will be cured with a light source. A second layer of the Icon Infiltrate was applied and cured in the same way. For Heliosael application, The sealant will be carefully applied starting from the maximum depth of the central fissure up towards two. Sealant retention will be evaluated using Simonsen's criteria. (Completely present: no sealant ledge is present, Partially present: part of the sealed pit or fissure, Complete missing: no sealant ledge is present.
Secondary Outcomes
- Evaluate and compare the microleakage and penetration depth of the two sealant materials(thirty seconds for application of Heliosael.The children will be recalled at 3, 6, and 9 months)