Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06493942

Clinical Efficiency of Bioactive Pit and Fissure Sealant

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

New bioactive resin pits and fissures sealant BioCoat® by Premier® presenting SmartCap™ Technology involving semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, supposing greater fluoride uptake in the presence of calcium and phosphate ions.

With no enough evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it isd beneficial to evaluate the newly introduced material using a randomized clinical trial to test the null hypothesis that bioactive resin pit and fissure sealant will have the same clinical performance as flouride releasing filled resin based pit and fissure sealant in susceptible fissures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion Criteria of participants:
  • 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.
  • Inclusion Criteria of teeth:
  • Caries susceptible occlusal pits and fissures.
  • Intact contact with opposing teeth.
  • Teeth with no previous restorations in other surfaces.

Exclusion criteria

  • Exclusion criteria of participants:
  • 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.
  • Exclusion criteria of teeth:
  • Carious pits and fissures.
  • Developmental tooth defect.
  • Partially erupted teeth
  • Periapical pathology or signs of pulpal pathology.
  • Tooth hypersensitivity.
  • Heavy occlusion and occlusal contacts.

Treatment and study plan

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.

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

Primary outcomes

  1. Retention of sealant

    Time frame: 1 year

    rate of sealant loss

Secondary outcomes

  1. Caries incidence

    Time frame: 1 year

    Rate of caries progression

Study contacts

Contact information is provided by the study sponsor or research team.

Samaa Salah, Msc

CONTACT

[email protected]

01009273452

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Evaluation of Bioactive Versus Filled Resin Based Pit & Fissure Sealants in First Permanent Molars: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.