Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02891876
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2016-08-30
Brief Title:
3-months Success Rate of Direct Pulp Capping With Biodentine
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
3-months Success Rate of Direct Pulp Capping With Biodentine
Status:
COMPLETED
Status Verified Date:
2017-11
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:
CPDB
Brief Summary:
Biodentine is a most recent material for direct pulp capping The aim of this study is to determine the 3 months success rate defined as clinical and radiographic successes together of direct pulp capping realized with Biodentine
Detailed Description:
Context When a pulpal exposure happens on a vital tooth without irreversible inflammation direct pulp capping can be realized by using different biomaterials CaOH2 MTA or Biodentine Biodentine is the most recent material and its success rate for direct pulp capping is poorly documented
Objective The main aim of this study is to determine the 3 months success rate defined as clinical and radiographic successes together of direct pulp capping realized with Biodentine The other aims are to determine the factors which have an influence over the success or the failure of direct pulp capping
Method The patients non-opposition is obtained after a loyal explanation of the study in order to collect clinical data if a pulpal exposure 2mm happens on a vital tooth during decy excavation
The operator registers the following data age of the patient type of the concerned tooth volume of coronal pulp surface of the pulp exposure location area and duration of pulp bleeding An evaluation is realized 3 months later with the same clinical evaluation and a radiographic evaluation If the pulp vitality is normal the final coronal filling is then realized
A statistical analysis will be performed to determine the success rate binomial distribution with p005 The predictive factors of success or failure will be analyzed with a logistic regression with p005
Objective The main aim of this study is to determine the 3 months success rate defined as clinical and radiographic successes together of direct pulp capping realized with Biodentine The other aims are to determine the factors which have an influence over the success or the failure of direct pulp capping
Method The patients non-opposition is obtained after a loyal explanation of the study in order to collect clinical data if a pulpal exposure 2mm happens on a vital tooth during decy excavation
The operator registers the following data age of the patient type of the concerned tooth volume of coronal pulp surface of the pulp exposure location area and duration of pulp bleeding An evaluation is realized 3 months later with the same clinical evaluation and a radiographic evaluation If the pulp vitality is normal the final coronal filling is then realized
A statistical analysis will be performed to determine the success rate binomial distribution with p005 The predictive factors of success or failure will be analyzed with a logistic regression with p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None