Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-8
SponsorTanta University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ICON resin infiltration Material group in vivo
DrugThe fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK).
Resin-based fissure sealant group in vivo
DrugThe fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)
ICON resin infiltration in vitro
DrugThe fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) in vitro
Resin-based fissure sealant in vitro
DrugThe fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael) in vitro
Treatment groups
86 Participants
are divided into 4 treatment groupsGroup A: ICON resin infiltration group (in vivo)Experimental treatment 1 intervention
Group B: Resin-based fissure sealant group (in vivo)Placebo comparator 1 intervention
Group C: ICON resin infiltration Material (in vitro)Experimental treatment 1 intervention
Group D: Resin-based fissure sealant (in vitro)Placebo comparator 1 intervention
Trial outcomes
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.
Time frame
3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 monthsSecondary outcomes
1
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.
Time frame
thirty seconds for application of Heliosael.The children will be recalled at 3, 6, and 9 monthsSponsors and contacts
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Source ClinicalTrials.gov
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