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Clinical Trials in Egypt / NCT06729788
Starting soon Phase 4

Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars

NCT06729788 · tracked via the Priya Life Science Egypt tracker
Sponsor
Tanta University
Phase
Phase 4
Started
2025-01-04
Last updated
2024-12-11

Condition(s) studied

Resin InfiltrationPit and Fissure SealantPermanent Molars

Investigational drug(s) / intervention(s)

ICON resin infiltration Material group in vivoResin-based fissure sealant group in vivoICON resin infiltration in vitroResin-based fissure sealant in vitro

ICON resin infiltration Material group in vivo: The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK).

Resin-based fissure sealant group in vivo: The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
8 Years
Healthy volunteers
Accepted
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 outcome measure(s)

  • Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria. — 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.

Trial sites (1)

FacilityCityRegionStatus
Salsabeel M Abdelgaffar Tanta ELGharbia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06729788 on ClinicalTrials.gov ↗ ← All trials in Egypt