NCT06514053

Prognostic Biomarkers for Pulpotomy Outcome

Discovering Prognostic Biomarkers for Pulpotomy Outcome in Permanent Mature Teeth With Irreversible Pulpitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Pulpitis - Irreversible

Interventions

Type	Name	Description
PROCEDURE	Full pulpotomy	A full pulpotomy will be performed by removing the entire roof of the pulp chamber and the remaining pulp tissue will be covered by Biodentine.
PROCEDURE	Root canal treatment	The regular procedure of root canal treatment will be performed on teeth with irreversible pulpitis

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-07-23
• Last updated: 2024-07-23

Locations

1 site across 1 country: Hong Kong