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

NCT07052526 | Not Yet Recruiting DMC

• 1 other identifier: MU-DPH-Heba2025
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries

Keywords

Hydrophilic sealant;; Fluoride; Microleakage; Caries; Retention

Outcome Measures

Primary Outcomes (2)

• Retention

  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 1. Partial sealant loss no caries Partial loss Acceptable 2. Sealant completely lost no caries Total loss Less ideal 3. Sealant partially or totally lost caries present Partial or total loss Worst outcome

  18 months

• Caries

  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

  18 months

Secondary Outcomes (2)

• Microleakage

  3 months

• Fluoride release

  2months

Study Arms (3)

Helioseal Fplus

EXPERIMENTAL

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

Other: Prevention

1 - Hydrophilic Sealant (Embrace WetBond)

EXPERIMENTAL

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

Other: Prevention of caries

Denu seal

EXPERIMENTAL

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.

Other: Prevention therapy

Interventions

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.

Also known as: Helioseal-F plus

Helioseal Fplus

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.

Also known as: Hydrophilic Embrace-Wetbond

1 - Hydrophilic Sealant (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

Also known as: Denuseal

Denu seal

Eligibility Criteria

• Age: 5 Years - 7 Years
• Gender Eligibility Details: All
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Cavitated caries
• fluorosis
• hypoplasia
• restored teeth

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Facility of Dentistry،Mansoura University

Al Mansurah, Egypt

Location

Related Links

• 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

MeSH Terms

Conditions

Dental Caries

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Dr rabaa MAHMOUD ABOU Bakr, Professor

  Mansoura University - Pediatric Dentistry Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Heba Mohamed DEGHID, Master

CONTACT

2001016684174; Heba.pl70@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer

Model Details: A total of 150 children aged 5-7 will be randomly assigned to three equal groups of 50 participants each

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2 years
• Access Criteria: Researcher

Locations

EG (1)