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

NCT07018141 | Not Yet Recruiting DMC

• 1 other identifier: Operative 4
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pit and Fissure Caries

Keywords

Pit and Fissure Caries

Outcome Measures

Primary Outcomes (1)

• retention of wear resistance of the sealants

  modified USPHS criteria

  3,6,9 and 12 months

Secondary Outcomes (1)

• quantitative wear assesment

  12 months

Study Arms (3)

Fluoride Releasing bioactive Pit and Fissure Sealant with etchant

EXPERIMENTAL

Fluoride Releasing bioactive Pit and Fissure Sealant with etchant application.

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

Fluoride Releasing bioactive Pit and Fissure Sealant without etchant application.

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

Conventional resin-based sealant with etchant application

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

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 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 with etchant

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

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.

Fluoride Releasing bioactive Pit and Fissure Sealant without etchant

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 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.

conventional resin based pits and fissure sealant

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Van der Woude syndrome

Interventions

Pit and Fissure Sealants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

rana hossam eldin, master

CONTACT

01004698643; rana.hossam@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree student dentist

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 12, 2025
• Study Start: August 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06