Prognostic Biomarkers for Pulpotomy Outcome

NCT06514053 | Recruiting

• 1 other identifier: UW 23-133
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (2)

• Success rate

  Success rate of full pulpotomy and RCT in teeth with irreversible pulpitis

  2 years

• Biomarkers

  Quantitative descriptive analysis of the expression of biomarkers commonly found in tissue inflammation using multiplex immunoassay (Millipore, USA). The kits include targets as follows: sCD40L;EGF;Eotaxin;FGF-2;Flt-3 ligand;Fractalkine;G-CSF;GM-CSF;GROα;IFNα2;IFNγ;IL-1α;IL-1β;IL-1ra;IL-2;IL-3;IL-4;IL-5;IL-6;IL-7;IL-8;IL-9;IL-10;IL-12 (p40);IL-12 (p70);IL-13;IL-15;IL-17A;IL-17E/IL-25;IL-17F;IL-18;IL-22;IL-27;IP-10;MCP-1;MCP-3;M-CSF;MDC (CCL22);MIG;MIP-1α;MIP-1β;PDGF-AA;PDGF-AB/BB;RANTES;TGFα;TNFα;TNFβ;VEGF-A; MMP-1, -2, -7, -9, -10.

  2 years

Secondary Outcomes (1)

• Correlation

  2 years

Study Arms (2)

Full pulpotomy

ACTIVE COMPARATOR

Procedure: Full pulpotomy

Root canal treatment

ACTIVE COMPARATOR

Procedure: Root canal treatment

Interventions

Full pulpotomy PROCEDURE

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.

Full pulpotomy

Root canal treatment PROCEDURE

The regular procedure of root canal treatment will be performed on teeth with irreversible pulpitis

Root canal treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent molars showing clinical and radiographic evidence of a deep carious lesion (extend to the three-quarters thickness of dentine radiographically) extending close to the pulp chamber
• Clinical diagnosis of irreversible pulpitis, including spontaneous pain, lingering pain with cold stimulation, no or mild tenderness to percussion, normal apical tissue or widening of the periodontal ligament space but with no signs of periapical periodontitis (i.e., PAI score 1 or 2)
• Positive response to cold and electric pulp test.

You may not qualify if:

• Tooth with no response to the cold and electric tests, presence of apical radiolucency (greater than periodontal widening), signs of canal calcification and resorption, history of trauma, unrestorable or nonfunctional teeth, and evidence of perio-endo lesion
• Intraoperative bleeding time is more than 10 minutes or less than 10 μL pulpal blood can be obtained
• Patients with a compromised immune status (such as HIV or organ transplant) or with any history of taking analgesics/antibiotics in the past one week.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Clinical Research Centre, Faculty of Dentistry, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Chengfei Zhang

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Cen

CONTACT

+852 28590290; cenrong@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: July 23, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

HK (1)