NCT04902495

Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements

Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Universitat Internacional de Catalunya · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to evaluate the success rate of pulpotomies in temporary molars using different types of hemostats and pulp coating materials based on tricalcium silicates, in patients who have attended the Dental Clinic of the International University of Catalonia (UIC).

Detailed description

This prospective randomized clinical trial study has been approved by the Scientific Committee in January of 2017 and by Ethics Committee (END-ECL- 2017-01) . It will be conducted in patients needing a vital pulp therapy treatment at the Pediatric Dentistry Department of Universitat Internacional de Catalunya (Sant Cugat del Vallés, Barcelona, Spain). The necessary statistical sample size assuming an alpha risk of 0.05, a beta risk of 0.05 and a power of 95% sample, the required sample obtained by group resulted in 52. Given an estimate upwards of 20% of drop-outs in controls, the final size results in 62.4 (63 cases per group). The data collection will be recollected using Excel program. Statgraphics Centurion XV software (StatPoint Technologies, Inc., Warrenton, VA, USA) will be used for statistical analysis. The chi-square test will be used and logistic regression analysis of the results will be performed to assess differences between groups with a significance level of P \<0.05.

Conditions

• Primary Molar Pulpotomy

Interventions

Type	Name	Description
OTHER	MTA Pro Root	pulp therapy
OTHER	MTA HP Repair	pulp therapy
OTHER	Biodentine	pulp therapy

Timeline

• Start date: 2017-01-12
• Primary completion: 2024-11-01
• Completion: 2024-12-12
• First posted: 2021-05-26
• Last updated: 2024-04-05

Locations

1 site across 1 country: Spain