NCT07094854

Clinical Performance and Antibacterial Effect of Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars

Clinical Performance and Antibacterial Effect of a Bulk Fill Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars(Randomized Controlled Clinical Trial)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Noha Fouad · Academic / Other
• Sex: All
• Age: 5 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the clinical performance of Cention-Forte (CF) material in the restoration of pulpotomized second primary molars compared to conventional stainless steel crowns (SSC), and also to assess the restorations' antibacterial effect on salivary cariogenic bacterial count.

Detailed description

A two-arm randomized controlled clinical trial. A total of 40 healthy cooperative children aged 5-9 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Each child selected will have second primary molar with occluso-proximal carious lesions indicated for pulpotomy. Written informed consent will be obtained from their guardians. After the MTA pulpotomy procedure, participants will be randomly allocated into two groups according to the restoration used. Group I (test group n=20) will receive Cention Forte material, while group II (control group n=20) will receive conventional SSC. Using Modified Ryge's Criteria, the clinical performance of the restorations will be evaluated at 1 week and then after 3, 6 and 12 months for marginal adaptation, proximal contact, retention, gross fracture, occlusal wear, surface roughness and secondary caries. Periapical radiographs will be taken at baseline and after 6 and 12 months. Also, the antibacterial effect of the restorations on salivary cariogenic bacterial count will be assessed at baseline and after 1 week, 1 month and 3 months. Plaque and Gingival index scores as well as parental and child's satisfaction will be recorded. Data will be collected, tabulated, and statistically analysed to obtain the results and conclusions of this study.

Conditions

• Healthy Children

Interventions

Type	Name	Description
OTHER	Cention Forte alkasite bioactive restorative material	Cention forte material will be used as a final restoration for pulpotomized second primary molars
OTHER	Stainless steel crown	The control group using the gold standard stainless steel crown (SSC) as a final restoration for pulpotomized second primary molars

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-07-30
• Last updated: 2025-07-30

Locations

2 sites across 1 country: Egypt