Comparative Evaluation of Hydrophilic and Hydrophobic Sealants in Partially Erupted First Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prevention, Prevention of caries, Prevention therapy.
- Who it may be relevant to
- Registry conditions: Dental Caries. Basic parameters: 5 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Hydrophilic and Hydrophobic Sealants' Retention, Caries Prevention, Microleakage, and Fluoride Release in Partially Erupted First Permanent Molars:A Randomized Controlled Clinical Trial
Overview
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.
Interventions
- 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
Primary outcome measures
- Retention [Time frame: 18 months]
- Caries [Time frame: 18 months]
Secondary outcome measures (2)
- Microleakage [Time frame: 3 months]
- Fluoride release [Time frame: 2months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Facility of Dentistry،Mansoura University — Al Mansurah
Identifiers
NCT: NCT07052526 · MU-DPH-Heba2025