Wear Resistance Of Bioactive With And Without Etching Vs. Conventional Resin-Based Fissure Sealants

NCT ID: NCT07018141

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-10-31

Brief Summary

This randomized clinical trial aimed to compare the wear resistance and clinical performance of bioactive versus conventional resin-based pit and fissure sealants over a 12-month period. Conducted on young adults with sound, caries-susceptible molars, the study evaluated three groups: bioactive sealants applied with and without etching, and conventional resin-based sealants with etching. Clinical assessments and 3D digital scans were used to measure sealant retention and wear. The study seeks to determine whether bioactive sealants, especially when applied without etching, provide comparable long-term protection and durability to conventional sealants, potentially simplifying application without compromising effectiveness.

Detailed Description

This study is a randomized controlled clinical trial designed to evaluate and compare the wear resistance and clinical performance of bioactive pit and fissure sealants-applied with and without acid etching-against conventional resin-based sealants in young adults aged 18-25 with caries-susceptible, sound first permanent molars. Seventy-five teeth were randomly assigned to three groups: Group 1 received a bioactive giomer-based sealant (BeautiSealant) with etching, Group 2 received the same sealant without etching, and Group 3 received a conventional resin-based sealant (Fisseal Promedica) with etching. Sealant retention and wear were evaluated clinically using modified USPHS criteria and digitally using intraoral 3D scanning at baseline, 6 months, and 12 months. The aim was to determine if omitting the etching step in bioactive sealants compromises their effectiveness, offering a simpler yet reliable alternative to conventional methods. The findings are expected to guide clinical decision-making on the most efficient and durable sealant protocols for caries prevention.

Conditions

Pit and Fissure Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Fluoride Releasing bioactive Pit and Fissure Sealant with etchant

Fluoride Releasing bioactive Pit and Fissure Sealant with etchant application.

Group Type: EXPERIMENTAL

Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phosp

Intervention Type: OTHER

This group received BeautiSealant (a bioactive giomer-based sealant) applied after etching the enamel surface with 37% phosphoric acid for 15 seconds. The etching process creates micro-retentive patterns in the enamel to enhance micromechanical bonding, potentially improving the sealant's retention and wear resistance while also benefiting from the bioactive material's fluoride release and enamel remineralization properties.

Fluoride Releasing bioactive Pit and Fissure Sealant without etchant

Fluoride Releasing bioactive Pit and Fissure Sealant without etchant application.

Group Type: EXPERIMENTAL

Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effecti

Intervention Type: OTHER

In this group, BeautiSealant was applied directly to the tooth surface without prior etching. The goal was to simplify the procedure by eliminating the etching step, relying instead on the sealant's chemical bonding and bioactive properties (such as fluoride release and S-PRG technology) to maintain retention and resist wear, while reducing the risk of enamel alteration and improving clinical efficiency.

conventional resin based pits and fissure sealant

Conventional resin-based sealant with etchant application

Group Type: ACTIVE_COMPARATOR

Conventional Resin-Based Sealant with Etching (Control): This group received a conventional resin-based sealant (Fisseal, Promedica) following standard acid etching. This technique represents the trad

Intervention Type: OTHER

This group served as the control and received Fisseal (a conventional resin-based sealant) applied following standard etching with 37% phosphoric acid. This method is considered the gold standard for fissure sealing, offering strong micromechanical adhesion and proven wear resistance, making it a reliable benchmark for evaluating the performance of newer bioactive materials.

Interventions

Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phosp

This group received BeautiSealant (a bioactive giomer-based sealant) applied after etching the enamel surface with 37% phosphoric acid for 15 seconds. The etching process creates micro-retentive patterns in the enamel to enhance micromechanical bonding, potentially improving the sealant's retention and wear resistance while also benefiting from the bioactive material's fluoride release and enamel remineralization properties.

Intervention Type: OTHER

Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effecti

In this group, BeautiSealant was applied directly to the tooth surface without prior etching. The goal was to simplify the procedure by eliminating the etching step, relying instead on the sealant's chemical bonding and bioactive properties (such as fluoride release and S-PRG technology) to maintain retention and resist wear, while reducing the risk of enamel alteration and improving clinical efficiency.

Intervention Type: OTHER

Conventional Resin-Based Sealant with Etching (Control): This group received a conventional resin-based sealant (Fisseal, Promedica) following standard acid etching. This technique represents the trad

This group served as the control and received Fisseal (a conventional resin-based sealant) applied following standard etching with 37% phosphoric acid. This method is considered the gold standard for fissure sealing, offering strong micromechanical adhesion and proven wear resistance, making it a reliable benchmark for evaluating the performance of newer bioactive materials.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients aged between 18-25 years old with caries susceptible sound fissures and good oral hygiene
• They should not show any signs of caries by visual tactile examination method and VistaProof fluoroscent camera
• Teeth should have intact contact with opposing teeth, no previous restorations in other surfaces, no previous sealing procedures and scoring 0.9 or less when tested and VistaProof.
• Medically free patients.

Exclusion Criteria

• Patients with poor oral hygiene, lack of compliance, parafunctional habits, tempro-mandibular joint disorders, periodontal disease, severe medical conditions, allergic history concerning methacrylates, rampant caries, heavy smoking and xerostomia.
• Teeth with caries pits and fissures, developmental anomalies, periapical pathology or signs of pulpal pathology, hypersensitivity, possible prosthodontic restoration, heavy occlusion and occlusal contacts, history of bruxism, severe periodontal affection and scoring >0.9 when tested with VistaProof

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rana hossam eldin mahfouz

Master degree student dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

rana hossam eldin, master

Role: CONTACT

rana.hossam@dentistry.cu.edu.eg

01004698643

Other Identifiers

Operative 4

Identifier Type: -

Identifier Source: org_study_id