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

NCT07399340 | Not Yet Recruiting

• 1 other identifier: CU-Pedo-2026
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pits and Fissure Sealants

Keywords

Self-adhering flowable composite; Conventional pits and fissure sealant; Helioseal-F; Vertise Flow; Fissurotomy; Permanent molars

Outcome Measures

Primary Outcomes (1)

• Sealant retention

  Simonsen's criteria Score 1: Complete retention Score 2: Partial loss Score 3: Complete loss

  3,6,12 months

Secondary Outcomes (3)

• Presence of Caries

  3,6,12 months

• Marginal discoloration

  3,6,12 months

• Marginal Integrity

  3,6,12 months

Study Arms (4)

Self adhering flowable composite Vertise™ Flow with fissurotomy

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.

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

Self adhering flowable composite Vertise™ Flow without fissurotomy

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.

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

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

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.

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

Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.

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.

Other: Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.

Interventions

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

1. 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) 2. Then washing and drying the tooth with compressed air. 3. 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) 4. Excess material around the margins will be removed. 5. After ensuring that there are no bubbles, the sealant will be cured for 20 seconds by light cure. (Woodpecker RTA Mini S, China). 6. If necessary, another layer will be applied and cured for 20 seconds.

Self adhering flowable composite Vertise™ Flow with fissurotomy

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

1. 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. 2. 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) 3. Remove excess material around the margins. 4. After ensuring that there are no bubbles, the sealant will be cured for 20 seconds by light cure. (Woodpecker RTA Mini S, China). 5. If necessary, another layer will be applied and cured for 20 seconds.

Self adhering flowable composite Vertise™ Flow without fissurotomy

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

1. 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) 2. 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. 3. 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).

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

Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy. OTHER

1. 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. 2. 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 )

Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• National Research Centre, Egypt: collaborator

Study Sites (2)

Faculty of Dentistry, Cairo University

Cairo, State/Province *, 11411, Egypt

Location

Faculty of Dentistry, Cairo University

Cairo, State/Province *, Egypt

Location

Study Officials

• Adel ELbardissy, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Eman MM Ramadan, Bachelors'

CONTACT

+201121592653; eman.ramadan@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The blinding of the operator is not possible due to the nature of the materials used and fissurotomy preparation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)