NCT07052526

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

Evaluation of Hydrophilic and Hydrophobic Sealants' Retention, Caries Prevention, Microleakage, and Fluoride Release in Partially Erupted First Permanent Molars:A Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.
OTHER	Prevention therapy	DENU Seal applied using a split-mouth design to evaluate bonding and non-bonding application outcomes from retention and caries prevention

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-01-01
• Completion: 2027-04-01
• First posted: 2025-07-04
• Last updated: 2025-07-09

Locations

1 site across 1 country: Egypt