Resin Infiltrate As Pit and Fissure Sealant in Permanent Molars

Evaluation of Resin Infiltrate As Pit and Fissure Sealant in Permanent Molars (In Vivo& in Vitro)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Permanent Molars; Pit and Fissure Sealant; Resin Infiltration
• Intervention / Treatment: Drug: ICON resin infiltration Material group in vivo; Drug: Resin-based fissure sealant group in vivo; Drug: ICON resin infiltration in vitro; Drug: Resin-based fissure sealant in vitro

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.

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Salsabeel M Abdelgaffar, B.D.S; Phone Number: +20 11 17010546; Email: PG_170913@dent.tanta.edu.eg

Study Locations

• Egypt
  • ELGharbia
    • Tanta, ELGharbia, Egypt, 31527
      • Salsabeel M Abdelgaffar
      • Contact: Salsabeel M Abdelgaffar, B.D.S; Phone Number: +20 11 17010546; Email: PG_170913@dent.tanta.edu.eg
      • Contact: Fatma A El-Hendawy, Professor
      • Contact: Ahmed I El Dosoky, Assistant Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICON resin infiltration group (in vivo); The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK)	Drug: ICON resin infiltration Material group in vivo; The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK).
Placebo Comparator: Resin-based fissure sealant group (in vivo); The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)	Drug: Resin-based fissure sealant group in vivo; The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)
Experimental: ICON resin infiltration Material (in vitro); The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK)	Drug: ICON resin infiltration in vitro; The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) in vitro
Placebo Comparator: Resin-based fissure sealant (in vitro); The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)**	Drug: Resin-based fissure sealant in vitro; The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael) in vitro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate and compare the microleakage and penetration depth of the two sealant materials	20 teeth will be randomly assigned into two equal experimental groups . Experimental Group I: The fissure of selected teeth will be sealed with ICON resin infiltration. Experimental Group II: The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael). After removal from the dye teeth will be rinsed with water, cleaned, and sectioned longitudinally through the center of the restorations in a buccolingual direction with a double-sided diamond disc and will be given a code number to permit blind evaluation. For each specimen, the dye penetration along the buccal and lingual margins on each sectioned surface will be digitally photographed at 10x under a stereomicroscope. The degree of microleakage was scored by a single observer.	thirty seconds for application of Heliosael.The children will be recalled at 3, 6, and 9 months

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 4, 2025
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): December 24, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Resin Infiltrate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes