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Self-Adhesive Flowable Composite vs Conventional Sealant in Permanent Molars Retention

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Study Aim

This study aims to compare the retention of self-adhesive flowable composite sealants versus conventional sealants in permanent molars using Simonsen's criteria, with the goal of preventing tooth decay.

What is being tested

Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy.

+ Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy.

+ Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.

Other
Who is being recruted

From 6 to 8 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorCairo University
Study ContactEman MM Ramadan, Bachelors'
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on comparing two types of dental sealants in children aged 6-8 years. The first is a self-adhering flowable composite, and the second is a conventional resin-based sealant. These sealants are applied to the newly erupted permanent first molars, with and without a procedure called fissurotomy. The main goal is to see which sealant works better and lasts longer in preventing dental caries, or cavities, in the deep grooves of these teeth. This research is important because it aims to find the best way to protect children's teeth, which could lead to fewer cavities and improved dental care. In this study, 88 children are divided into four groups. Each group receives one of the following: self-adhering flowable composite with fissurotomy, self-adhering flowable composite without fissurotomy, conventional resin-based sealant with fissurotomy, or conventional resin-based sealant without fissurotomy. The main outcome measured is sealant retention, or how well the sealant stays in place. This is evaluated using a scoring system called Simonsen's criteria. Other outcomes include the development of cavities, marginal discoloration, and marginal integrity, which are assessed using Ryge criteria. These checks are done at the start of the study, and then after 3, 6, and 12 months.

Official TitleA Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Retention Versus Conventional Pits and Fissure Sealant With and Without Fissurotomy in Permanent Molars: A Randomized Controlled Trial
Principal SponsorCairo University
Study ContactEman MM Ramadan, Bachelors'
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

88 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 8 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
Normal healthy children aged 6 to 8 years.

Children with high caries risk

Completely erupted lower first permanent molars with deep pits and fissures.

Fissures either intact, sound or retentive which are stained, caries free or ICDAS 0-2.

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9 exclusion criteria prevent from participating
Children whose parents refuse to sign informed consent.

Long-term medication affecting the salivary flow.

Children enrolled for other studies or fluoridation program.

Adverse reaction reported to any dental material.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Vertise™ Flow (Kerr, Orange, CA, USA) Chemical composition: * Resin: GPDMA, HEMA, BisGMA, catalysts. * Fillers: Prepolymers, silanated Ba-glass, SiO2,YF3 (70 wt%). This SAFC uses the adhesive monomer glycerophosphate dimethacrylate GPDM, a phosphate functional group that creates a chemical bond with the calcium ions of the tooth. GPDM monomers ensure a tenacious bond to enamel, evidenced by the strength known to all generations of the OptiBond adhesive family.

Group II

Experimental
Vertise™ Flow (Kerr, Orange, CA, USA) Chemical composition: * Resin: GPDMA, HEMA, BisGMA, catalysts. * Fillers: Prepolymers, silanated Ba-glass, SiO2,YF3 (70 wt%). This SAFC uses the adhesive monomer glycerophosphate dimethacrylate GPDM, a phosphate functional group that creates a chemical bond with the calcium ions of the tooth. GPDM monomers ensure a tenacious bond to enamel, evidenced by the strength known to all generations of the OptiBond adhesive family.

Group III

Active Comparator
Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity Sealant Matrix Composition: 1. Bis-GMA 2. UDMA 3. TEGDMA Fillers: Fluorosilicate glass , highly dispersed silicon dioxide, pigments, initiators.

Group IV

Active Comparator
Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity Sealant Composition: 1. Bis-GMA 2. UDMA 3. TEGDMA Fillers: Fluorosilicate glass , highly dispersed silicon dioxide, pigments, initiators.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Faculty of Dentistry, Cairo University

Cairo, EgyptOpen Faculty of Dentistry, Cairo University in Google Maps
Suspended

Faculty of Dentistry, Cairo University

Cairo, Egypt
Recruiting soon2 Study Centers