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.

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.

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.