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

Official title

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

Overview

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.

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.

Interventions

• Other Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy.
  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 micr
• Other Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy.
  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, Orang
• Other Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.
  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 w
• Other Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.
  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 t

Primary outcome measures

• Sealant retention [Time frame: 3,6,12 months]

Secondary outcome measures (3)

• Presence of Caries [Time frame: 3,6,12 months]
• Marginal discoloration [Time frame: 3,6,12 months]
• Marginal Integrity [Time frame: 3,6,12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Egypt · 2 centers

• Faculty of Dentistry, Cairo University — Cairo
• Faculty of Dentistry, Cairo University — Cairo

Identifiers

NCT: NCT07399340 · CU-Pedo-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗