Clinical trial NCT06729788: Resin Infiltrate As Pit and Fissure Sealant in Permanent Molars
Official title: Evaluation of Resin Infiltrate As Pit and Fissure Sealant in Permanent Molars (In Vivo& in Vitro)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Resin Infiltration
Pit and Fissure Sealant
Permanent Molars
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 86
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria.
timeFrame: 3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 months
Secondary outcomes:
measure: Evaluate and compare the microleakage and penetration depth of the two sealant materials
timeFrame: thirty seconds for application of Heliosael.The children will be recalled at 3, 6, and 9 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Salsabeel M Abdelgaffar
state: ELGharbia
Study officials:
References:
citation: Lam PPY, Sardana D, Ekambaram M, Lee GHM, Yiu CKY. Effectiveness of Pit and Fissure Sealants for Preventing and Arresting Occlusal Caries in Primary Molars: A Systematic Review and Meta-Analysis. J Evid Based Dent Pract. 2020 Jun;20(2):101404. doi: 10.1016/j.jebdp.2020.101404. Epub 2020 Jan 29.