Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514053
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-17
Brief Title:
Prognostic Biomarkers for Pulpotomy Outcome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Discovering Prognostic Biomarkers for Pulpotomy Outcome in Permanent Mature Teeth With Irreversible Pulpitis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will recruit 180 molars diagnosed with irreversible pulpitis Full pulpotomy will be performed on 120 teeth while RCT root canal treatment will be conducted on another cohort of 60 teeth as the control for assessing long-term outcomes Additionally 12 blood samples and pulp tissues from healthy teeth receiving elective RCT will be collected as the controls The first pulpal blood sample will be collected after caries removal and pulp exposure Subsequently the entire coronal pulp tissue will be removed and collected for histological examination image-based spatial and scRNA-seq analyses A second pulpal blood sample will be collected from the radicular pulp tissue Both blood samples will be used to profile the inflammation-related biomarkers through multiplex immunoassays The remaining pulp tissue will be covered by Biodentine and restored with resin-based composite Pulpotomy treatment outcomes will be evaluated clinically and radiographically at 6 and 12 months The biomarkers identified in the pulpal blood and histology and the single-cell transcriptomes of the coronal pulp will be compared with the treatment success and failure groups upon one year The outcome of RCT will be compared with that of full pulpotomy at 24 months
Detailed Description:
None
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