NCT06736964

Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients

Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients :A Randomized Clinical Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to clinically evaluate three different bioactive restorative material in cervical carious lesion in high caries risk patients. Reducing the incidence of recurrent caries is the primary outcome

Detailed description

Bioactive restorative materials are relatively new concept in dentistry combines between esthetics, strength and resilience of composites with bioactive properties, the development of therapeutic bio-interactive materials results in tissue re-mineralization, reduces the susceptibility to tooth mineral loss, and recovers its mechanical properties . Patients, with high caries, have many risk factors like inadequate biofilm control, salivary flow deficiency, and altered host defense. Conventional restorative materials expose the tooth structure to stress concentration. Moreover, preserving the tooth restoration interface intact is great challenge to avoid recurrent caries, which may also result in restoration failures . This prospective study will be investigating and comparing the eighteen month clinical performance of a different bioactive restorative materials and a conventional Pre-reacted glass ionomer restorative material in class V cavity preparation.

Conditions

• Class V Dental Caries
• High Caries Risk Patients

Interventions

Type	Name	Description
DEVICE	Giomer	based on Pre-reacted glass ionomer (PRG)

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-12-17
• Last updated: 2024-12-17

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study