Resin Infiltrate As Pit and Fissure Sealant in Permanent Molars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-04

Study Completion Date

2025-12-24

Brief Summary

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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

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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

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Resin Infiltration Pit and Fissure Sealant Permanent Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

For the application of ICON, The cleaned fissure was etched using an Icon-Etch in its special syringe for 2 minutes. Then the tooth was rinsed off using water for at least 30 seconds and dried with oil-free and water-free air. Followed by application of the Icon-Dry applied into the fissure and let sit for 30 seconds. The excess of the Icon-Dry was removed and dried with oil-free and water-free air.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\* according to the manufacturer's instructions. A second layer of the Icon Infiltrate was applied and cured in the same way.

Study Groups

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ICON resin infiltration group (in vivo)

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

Group Type EXPERIMENTAL

ICON resin infiltration Material group in vivo

Intervention Type DRUG

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)

Group Type PLACEBO_COMPARATOR

Resin-based fissure sealant group in vivo

Intervention Type DRUG

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

ICON resin infiltration Material (in vitro)

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

Group Type EXPERIMENTAL

ICON resin infiltration in vitro

Intervention Type DRUG

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)\*\*

Group Type PLACEBO_COMPARATOR

Resin-based fissure sealant in vitro

Intervention Type DRUG

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

Interventions

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ICON resin infiltration Material group in vivo

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

Intervention Type DRUG

Resin-based fissure sealant group in vivo

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

Intervention Type DRUG

ICON resin infiltration in vitro

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

Intervention Type DRUG

Resin-based fissure sealant in vitro

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Salsabeel Mahmoud Abdelgaffar Shalaby

Dentist, Pediatric dentistry, Oral Health and Preventive Dentistry Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Salsabeel M Abdelgaffar

Tanta, ELGharbia, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Salsabeel M Abdelgaffar, B.D.S

Role: CONTACT

Phone: +20 11 17010546

Email: [email protected]

Facility Contacts

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Salsabeel M Abdelgaffar, B.D.S

Role: primary

Fatma A El-Hendawy, Professor

Role: backup

Ahmed I El Dosoky, Assistant Professor

Role: backup

References

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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.

Reference Type BACKGROUND

PMID: 32473795 (View on PubMed)

Other Identifiers

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