Comparative Evaluation of Hydrophilic and Hydrophobic Sealants in Partially Erupted First Molars
NCT ID: NCT07052526
Last Updated: 2025-07-09
Study Results
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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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2025-07-01
2027-04-01
Brief Summary
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Detailed Description
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A total of 150 children will be randomly assigned to three equal groups of 50 participants each. A split-mouth design will be used: in each group, sealants will be applied with and without bonding agents on opposite sides of the upper or lower arch, allowing intra-subject comparisons. Clinical evaluations will be conducted at 3, 6, 12, and 18 months to assess sealant retention and caries incidence using the modified Color, Coverage, Caries (CCC) Sealant Evaluation System.
In addition to the clinical phase, a laboratory phase will be conducted using extracted human premolars. This phase will evaluate microleakage and sealant penetration under a stereomicroscope following dye penetration techniques. Fluoride release will be measured at specified time intervals (1, 7, 14, 21, and 28 days) using an ion-selective electrode in artificial saliva conditions maintained at 37°C.
The primary outcomes include sealant retention and caries incidence. Secondary outcomes focus on the degree of microleakage, sealant penetration, and fluoride release. The trial will help determine whether moisture-tolerant sealants offer superior clinical and preventive benefits over traditional hydrophobic materials, particularly in situations where ideal isolation is difficult, such as with partially erupted teeth in young children.
The study will be conducted at the Pediatric Dentistry Clinic, Faculty of Dentistry, Mansoura University, and is expected to generate evidence that could improve clinical decision-making in preventive pediatric dentistry.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Helioseal Fplus
Participants in this arm will receive the Helioseal F Plus resin-based sealant, applied to occlusal surfaces of permanent molars. The sealant will be applied according to the manufacturer's
Prevention
Conventional Hydrophobic Sealant (Helioseal F - Control) will be used as a positive control; applied to partially erupted molars with and without bonding in a split-mouth design.
1 - Hydrophilic Sealant (Embrace WetBond)
Participants will receive Embrace WetBond sealant, a moisture-tolerant resin sealant applied to slightly moist occlusal surfaces. The sealant is light-cured for 20 seconds
Prevention of caries
Embrace WetBond sealant will be applied to partially erupted first permanent molars using a split-mouth design with and without bonding agent.
Denu seal
Participants in this arm will receive Denuseal, a fluoride-releasing sealant, applied to occlusal surfaces of permanent molars under dry conditions. The sealant will be light-cured for 20 seconds.
Prevention therapy
DENU Seal applied using a split-mouth design to evaluate bonding and non-bonding application outcomes from retention and caries prevention
Interventions
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Prevention
Conventional Hydrophobic Sealant (Helioseal F - Control) will be used as a positive control; applied to partially erupted molars with and without bonding in a split-mouth design.
Prevention of caries
Embrace WetBond sealant will be applied to partially erupted first permanent molars using a split-mouth design with and without bonding agent.
Prevention therapy
DENU Seal applied using a split-mouth design to evaluate bonding and non-bonding application outcomes from retention and caries prevention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* good oral hygiene (OHI-S Index),
* 2 partially erupted 1st molars
Exclusion Criteria
* fluorosis
* hypoplasia
* restored teeth
5 Years
7 Years
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Heba Mohamed
Assisstant lecturer
Principal Investigators
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Dr rabaa MAHMOUD ABOU Bakr, Professor
Role: PRINCIPAL_INVESTIGATOR
Mansoura University - Pediatric Dentistry Clinic
Locations
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Facility of Dentistry،Mansoura University
Al Mansurah, , Egypt
Countries
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Central Contacts
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Related Links
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This randomized controlled trial compared hydrophilic (UltraSeal XT Hydro) and hydrophobic (Helioseal-F) resin-based sealants in uncooperative childre in aged 6-9 years. Using a split-mouth design, sealants were applied to 49 pairs of molars and assessed
In-vitro studies on pit and fissure sealants often involve measuring fluoride ion release to assess their potential anticariogenic effects. Fluoride release is typically measured using a fluoride ion-selective electrode and an ion analyzer. Different typ
Other Identifiers
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MU-DPH-Heba2025
Identifier Type: -
Identifier Source: org_study_id
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