Clinical Efficiency of Bioactive Pit and Fissure Sealant

NCT06493942 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: BPFS
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing filled resin based pits and fissure sealant in posterior molars prone to carious lesions of fissures in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.

Conditions

Pit and Fissure Sealant

Keywords

dental sealant; pit and fissure sealant; fissure sealant; Bioactive dental sealant; Tooth sealant; Fissure sealants; Dental sealants; Pit sealants

Outcome Measures

Primary Outcomes (1)

• Retention of sealant

  rate of sealant loss

  1 year

Secondary Outcomes (1)

• Caries incidence

  1 year

Study Arms (2)

Control group (A)

ACTIVE COMPARATOR

Fluoride releasing filled resin based pit and fissure sealant using UltraSeal XT™ plus by Ultradent

Other: UltraSeal XT™ plus by Ultradent

Interventional group (B)

EXPERIMENTAL

Bioactive pit and fissure sealant using BioCoat® by Premier®

Other: BioCoat® by Premier®

Interventions

BioCoat® by Premier® OTHER

BioCoat is a 56% filled resin formula that provides added strength and excellent long-term resistance to wear ؤomparable to flowable composites.

Interventional group (B)

UltraSeal XT™ plus by Ultradent OTHER

UltraSeal XT plus is a 58%-filled resin fluoride-releasing sealant. It is strong and has high wear resistant

Control group (A)

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients with caries susceptible fiss- ures in fully erupted first permanent molars showing nosigns of caries.
• Co-operative patients approving to part- icipate in the trial.
• Good oral hygiene.
• Caries susceptible occlusal pits and fissures.
• Intact contact with opposing teeth.
• Teeth with no previous restorations in other surfaces.

You may not qualify if:

• patients with Disabilities, systemic disease or severe medical complications.
• patients have allergic history concerning methacrylate.
• patients with rampant caries, xerostomia, evidence of severe bruxism, clenching, or tempromandibular joint disorders
• participants who show lack of compliance.
• Carious pits and fissures.
• Developmental tooth defect.
• Partially erupted teeth
• Periapical pathology or signs of pulpal pathology.
• Tooth hypersensitivity.
• Heavy occlusion and occlusal contacts.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Van der Woude syndrome

Interventions

Ultra Seal XT

Central Study Contacts

Samaa Salah, Msc

CONTACT

01009273452; samaa.salah@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding to participants : will not know either the intervention or the comparator will be applied to their teeth Blinding to investigator: covering the 2 syringes with opaque seal to avoid performance bias Blinding to outcomes assessor: to overcome detection bias
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in pediatric dentistry department, faculty of Dentistry

Model Details: Randomized control trial

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: August 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07