Resin Infiltrate As Pit and Fissure Sealant in Permanent Molars

NCT06729788 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Resin Infiltrate
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Resin Infiltration; Pit and Fissure Sealant; Permanent Molars

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 months

Secondary Outcomes (1)

• 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

Study Arms (4)

ICON resin infiltration group (in vivo)

EXPERIMENTAL

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

Drug: ICON resin infiltration Material group in vivo

Resin-based fissure sealant group (in vivo)

PLACEBO COMPARATOR

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

Drug: Resin-based fissure sealant group in vivo

ICON resin infiltration Material (in vitro)

EXPERIMENTAL

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

Drug: ICON resin infiltration in vitro

Resin-based fissure sealant (in vitro)

PLACEBO COMPARATOR

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

Drug: Resin-based fissure sealant in vitro

Interventions

ICON resin infiltration Material group in vivo DRUG

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

ICON resin infiltration group (in vivo)

Resin-based fissure sealant group in vivo DRUG

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

Resin-based fissure sealant group (in vivo)

ICON resin infiltration in vitro DRUG

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

ICON resin infiltration Material (in vitro)

Resin-based fissure sealant in vitro DRUG

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

Resin-based fissure sealant (in vitro)

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Salsabeel M Abdelgaffar

Tanta, ELGharbia, 31527, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32473795 BACKGROUND

MeSH Terms

Conditions

Van der Woude syndrome

Interventions

In Vitro Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Salsabeel M Abdelgaffar, B.D.S

CONTACT

+20 11 17010546; PG_170913@dent.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist, Pediatric dentistry, Oral Health and Preventive Dentistry Department

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 11, 2024
• Study Start: January 4, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 24, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

EG (1)