Comparative Evaluation of Hydrophilic and Hydrophobic Sealants in Partially Erupted First Molars

Mansoura University

Status: Not yet enrolling

Conditions: Dental Caries

Treatments: Other: Prevention; Other: Prevention of caries; Other: Prevention therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07052526

MU-DPH-Heba2025

Details and patient eligibility

About

This randomized controlled clinical trial aims to evaluate and compare the retention, caries prevention, microleakage, and fluoride release of three types of pit and fissure sealants-hydrophilic, nanofilled hydrophobic, and conventional hydrophobic-applied to partially erupted first permanent molars in children aged 5 to 7 years. The study uses a split-mouth design and includes both clinical and laboratory evaluations over an 18-month period. Outcomes will assess sealant effectiveness with and without the use of a bonding agent.

Full description

This is a randomized controlled clinical trial designed to evaluate and compare the effectiveness of three types of pit and fissure sealants-hydrophilic (Embrace WetBond), nanofilled hydrophobic (DENU Seal), and conventional hydrophobic (Helioseal F)-when applied to partially erupted first permanent molars in children aged 5 to 7 years. The study aims to assess the sealants' clinical retention, their ability to prevent dental caries, microleakage, sealant penetration depth, and fluoride release.

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 5 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Cooperative children (Frankl Scale 3)
• good oral hygiene (OHI-S Index),
• 2 partially erupted 1st molars

Exclusion Criteria:

• Cavitated caries
• fluorosis
• hypoplasia
• restored teeth

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Helioseal Fplus

Experimental group

Description:

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

Treatment:

Other: Prevention

1 - Hydrophilic Sealant (Embrace WetBond)

Experimental group

Description:

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

Treatment:

Other: Prevention of caries

Denu seal

Experimental group

Description:

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.

Treatment:

Other: Prevention therapy