Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-02-12 @ 3:44 AM
Study NCT ID:
NCT04902495
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2020-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements
Sponsor:
Universitat Internacional de Catalunya
Organization:
Study Overview
Official Title:
Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements.
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: