A 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 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

This RCT study aims to establish evidence-based decision comparing between self-adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) and conventional resin-based pits & fissure sealant Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) with and without fissurotomy in sealant retention and prevention of occlusal pits and fissures caries in first permanent molars over a 12-month follow-up.

Study Overview

• Status: Not yet recruiting
• Conditions: Pits and Fissure Sealants
• Intervention / Treatment: Other: Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy.; Other: Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy.; Other: Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.; Other: Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.

Detailed Description

This randomized controlled clinical trial aims to compare the retention and clinical performance of a self-adhering flowable composite and a conventional resin-based pit and fissure sealant, applied with and without fissurotomy, in newly erupted permanent first molars of children aged 6-8 years.

Occlusal pits and fissures are highly susceptible to dental caries in children, and long-term sealant effectiveness is strongly dependent on material retention and technique sensitivity. Self-adhering flowable composites offer simplified application with fewer clinical steps and may improve retention, especially in pediatric patients.

Eighty-eight children will be randomly allocated into four parallel groups (1:1:1:1): self-adhering flowable composite with fissurotomy, self-adhering flowable composite without fissurotomy, conventional resin-based sealant with fissurotomy, and conventional resin-based sealant without fissurotomy.

Sealant retention will be assessed as the primary outcome using Simonsen's criteria, while secondary outcomes include caries development, marginal discoloration, and marginal integrity evaluated using Ryge criteria.

Clinical evaluations will be performed at baseline, 3, 6, and 12 months.

The findings of this study aim to provide evidence-based guidance on the optimal material and technique for pit and fissure sealing in children, potentially improving sealant longevity, reducing occlusal caries incidence, and enhancing preventive pediatric dental care.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman MM Ramadan, Bachelors'; Phone Number: +201121592653; Email: eman.ramadan@dentistry.cu.edu.eg

Study Locations

• Egypt
  • State/Province *
    • Cairo, State/Province *, Egypt, 11411
      • Faculty of Dentistry, Cairo University
      • Contact: Phone Number: 00201121592653; Email: eman.ramadan@dentistry.cu.edu.eg
    • Cairo, State/Province *, Egypt
      • Faculty of Dentistry, Cairo University
      • Contact: Eman Ramadan, Bachelors'; Phone Number: 00201121592653; Email: eman.ramadan@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.
• Availability for the duration of the study.
• Satisfactory dental care performed at home.

Exclusion Criteria:

• 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.
• Uncooperative child.
• Bruxism or malocclusion.
• Children with developmental defects/ hypoplastic molars or caries affected teeth (ICDAS>2).
• Teeth with restoration and partially retained sealants.
• Children who cannot come for the follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self adhering flowable composite Vertise™ Flow with fissurotomy; 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.	Other: Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy.; Pits and fissures will be prepared using a Micro STF fissurotomy bur (SS White Burs Inc., Lakewood, NJ, USA) on a high-speed hand piece, the bur will be moved along all the occlusal fissures with a gentle force applied. (Bagherian et al., 2013); Then washing and drying the tooth with compressed air.; Then self-adhering flowable composite (Vertise Flow, Kerr, Orange, CA, USA) with an A2 shade will be applied on occlusal fissures in 0.5mm and brushed on preparation for 15-20sec using a micro-brush with moderate pressure. (Sabbagh et al., 2017; Sharma et al., 2018); Excess material around the margins will be removed.; After ensuring that there are no bubbles, the sealant will be cured for 20 seconds by light cure. (Woodpecker RTA Mini S, China).; If necessary, another layer will be applied and cured for 20 seconds.
Experimental: Self adhering flowable composite Vertise™ Flow without fissurotomy; 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.	Other: Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy.; Before applying Vertise Flow, surface pretreatment according to the manufacturers' recommendations for uncut enamel.(Kucukyilmaz and Savas, 2015) Using 37.5 % phosphoric acid gel Ivoclar Vivadent AG, Schaan, Liechtenstein) for 30-60 seconds according to the manufacturer's instructions, rinsed for 60 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance.; Then self-adhering flowable composite (Vertise Flow, Kerr, Orange, CA, USA) with an A2 shade will be applied in 0.5mm and brushed on fissures for 15-20sec using a micro-brush with moderate pressure.(Sabbagh et al., 2017; Sharma et al., 2018); Remove excess material around the margins.; After ensuring that there are no bubbles, the sealant will be cured for 20 seconds by light cure. (Woodpecker RTA Mini S, China).; If necessary, another layer will be applied and cured for 20 seconds.
Active Comparator: Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.; Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity Sealant Matrix Composition: Bis-GMA; UDMA; TEGDMA Fillers: Fluorosilicate glass , highly dispersed silicon dioxide, pigments, initiators.	Other: Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.; Pits and fissures will be prepared using a Micro STF fissurotomy bur (SS White Burs Inc., Lakewood, NJ, USA) on a high-speed hand piece, the bur will be moved along all the occlusal fissures with a gentle force applied. (Bagherian et al., 2013); Then the occlusal surface of the teeth will be dried and etched with 37% phosphoric acid (Ivoclar Vivadent AG, Schaan, Liechtenstein) for 15-30 seconds according to the manufacturer's instructions, rinsed for 30 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance.; Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) will be applied and directed into the pits and fissures by a sterile explorer to check that there are no air bubbles and light cured for 40 seconds by light cure. (Woodpecker RTA Mini S, China).
Active Comparator: Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.; Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity Sealant Composition: Bis-GMA; UDMA; TEGDMA Fillers: Fluorosilicate glass , highly dispersed silicon dioxide, pigments, initiators.	Other: Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.; The occlusal surface of the teeth will be dried and etched with 37% phosphoric acid (Ivoclar Vivadent AG, Schaan, Liechtenstein) for 30-60 seconds according to the manufacturer's instructions, rinsed for 30 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance.; Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) will be applied and directed into the pits and fissures by a sterile explorer to check that there are no air bubbles and light cured for 40 seconds by light cure. (Woodpecker RTA Mini S, China )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sealant retention	Simonsen's criteria Score 1: Complete retention Score 2: Partial loss Score 3: Complete loss	3,6,12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Caries	Ryge criteria Alpha: Absence of caries Bravo: Prescence of caries	3,6,12 months
Marginal discoloration	Ryge criteria Alpha: No discoloration anywhere on the margin around the sealant. Bravo: Visible partial discoloration on the margin around sealant. Charlie: Visible discoloration on the margin around all sealant.	3,6,12 months
Marginal Integrity	Ryge criteria Alpha: Sealant had full adaptation to the adjacent tooth structure. Bravo: Evidence of gap detected by the tip of an explorer.	3,6,12 months

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: National Research Centre, Egypt
• Investigators: Study Director: Adel ELbardissy, Professor, Cairo university

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Permanent molars; Self-adhering flowable composite; Conventional pits and fissure sealant; Helioseal-F; Vertise Flow; Fissurotomy
• Other Study ID Numbers: CU-Pedo-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No