Clinical trial NCT07018141: Wear Resistance Of Bioactive With And Without Etching Vs. Conventional Resin-Based Fissure Sealants
Official title: Clinical And Digital Evaluation Of Wear Resistance Of Bioactive Pits And Fissure Sealant With And Without Etching Versus Conventional Resin Based Pits And Fissure Sealants: A RANDOMIZED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pit and Fissure Caries
Keywords: Pit and Fissure Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: retention of wear resistance of the sealants
timeFrame: 3,6,9 and 12 months
Secondary outcomes:
measure: quantitative wear assesment
timeFrame: 12 months
Other outcomes:
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