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NCT Number: NCT07052526

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facility of Dentistry،Mansoura University

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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

Treatment and study plan

Prevention

Other

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 names: Helioseal-F plus

Prevention of caries

Other

Embrace WetBond sealant will be applied to partially erupted first permanent molars using a split-mouth design with and without bonding agent.

Other names: Hydrophilic Embrace-Wetbond

Prevention therapy

Other

DENU Seal applied using a split-mouth design to evaluate bonding and non-bonding application outcomes from retention and caries prevention

Other names: Denuseal

Primary outcomes

  1. Retention

    Time frame: 18 months

    retention is evaluated using CCC Index (Color, Coverage, and Caries)

    This scale is used to assess sealant retention and caries status during follow-up evaluations.

    Score Description Retention Caries Status Interpretation

    0 Sealant completely retained no caries Full retention Best outcome

    • Partial sealant loss no caries Partial loss Acceptable
    • Sealant completely lost no caries Total loss Less ideal
    • Sealant partially or totally lost caries present Partial or total loss Worst outcome

  2. Caries

    Time frame: 18 months

    Caries Incidence: 3, 6, 12, 18 months, t each recall (3, 6, 12 months), evaluate each sealed tooth using the CCC score:

    If the sealant is completely intact and no caries is visible → score = 0

    If the sealant is partially gone but no decay → score = 1

    If sealant is lost but still no decay → score = 2

    If sealant is lost/partial and there is decay → score = 3

Secondary outcomes

  1. Microleakage

    Time frame: 3 months

    Microleakage Assessment (lab) - dye penetration . Score Description Microleakage Depth Interpretation

    0 No dye penetration 0% of fissure depth Best outcome

    • Dye penetrates into enamel only <50% of enamel Good
    • Dye penetrates to dentino-enamel junction (DEJ) Reaches DEJ, no dentin Borderline
    • Dye penetrates into dentin Past DEJ into dentin Worst outcome

    Minimum score: 0 = no leakage

    Maximum score: 3 = extensive leakage

    Higher score = worse outcome

  2. Fluoride release

    Time frame: 2months

    Fluoride Release - spectrophotometer (1, 7, 14, 21, 28 days) Fluoride Release Scoring System (Modified Scale for Clinical Correlation)

    Because fluoride release is continuous and measured in ppm or µg/cm²/day, we can categorize release levels into scores for easier interpretation.

    Score Fluoride Release Level Typical Range Interpretation

    0 High, sustained release >2 ppm after 1 week Best outcome

    • Moderate release 1-2 ppm after 1 week Good
    • Low release 0.5-1 ppm after 1 week Weak effect
    • Negligible release <0.5 ppm after 1 week Ineffective

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Heba Mohamed DEGHID, Master

CONTACT

[email protected]

2001016684174

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 4, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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