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

Cairo University (CU)

Status: Begins enrollment in 1 month

Conditions: Pit and Fissure Caries

Treatments: Other: 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; 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; 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07018141

Operative 4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 3 patient groups

Fluoride Releasing bioactive Pit and Fissure Sealant with etchant

Experimental group

Description:

Fluoride Releasing bioactive Pit and Fissure Sealant with etchant application.

Treatment:

Other: 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

Fluoride Releasing bioactive Pit and Fissure Sealant without etchant

Experimental group

Description:

Fluoride Releasing bioactive Pit and Fissure Sealant without etchant application.

Treatment:

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

conventional resin based pits and fissure sealant

Active Comparator group

Description:

Conventional resin-based sealant with etchant application

Treatment:

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