Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

NCT05964933 | Enrolling By Invitation DMC

• 1 other identifier: DSRB 2023/00044
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomised controlled trial for complete pulpotomy as an alternative to root canal treatment for teeth with clinical diagnosis of symptomatic irreversible pulpitis (i.e. signs and symptoms indicative of irreversible pulpitis) conducted at the National University Centre for Oral Health Singapore (NUCOHS) Endodontic unit. Up to 70 teeth, 35 in each group, will be enrolled. Clinical and radiographic outcome data will be collected and analysed, and a parallel cost-effectiveness analysis will also be undertaken to examine the potential costs and benefits of pulpotomy. A process evaluation will also be conducted to assess the acceptability of the intervention to both dentists and patients, while exploring the barriers and enablers to implementation.

Conditions

Pulpitis - Irreversible

Keywords

dental caries; deep caries; pulpotomy; root canal treatment; vital pulp therapy

Outcome Measures

Primary Outcomes (1)

• Composite measure is defined by the change from baseline pain and radiographic status at 6 months and again at 12 months.

  Composite measure defined as: 1. absence of pain indicative of irreversible pulpitis; 2. absence of signs and symptoms indicative of acute or chronic periapical disease; 3. absence of radiographic evidence of failure including radiolucency or resorption.

  6, 12 months

Secondary Outcomes (6)

• Numeric Rate Scale (NRS): minimum value = 0 (best outcome), maximum value = 10 (worst outcome)

  3, 7 days

• Restoration: the restoration remains intact and adapts completely to the prepared cavity margins.

  6, 12 months

• A "yes" or "no" response when the Cold Test and Electric Pulp Test are applied on the treated tooth.

  6, 12 months

• N5. Clinicians examine the treated tooth to determine if there is pathology that resulted from the treatment.

  12 months

• Data to be collected include time spent on receiving the treatment, cost of treatment, and patients' willingness to pay for treatment.

  12 months

Study Arms (2)

Complete Pulpotomy

ACTIVE COMPARATOR

The tooth will be treated with Complete Pulpotomy.

Procedure: Complete Pulpotomy

Pulpectomy and Root Canal Treatment

ACTIVE COMPARATOR

The tooth will be treated with Pulpectomy and Root Canal Treatment.

Procedure: Pulpectomy and Root Canal Treatment

Interventions

Complete Pulpotomy PROCEDURE

Complete caries removal and excision of the entire coronal pulp to the level of the root canal orifices will be performed. After haemostasis, the pulp chamber will be filled with Biodentine® and a final direct restoration placed in 1 or 2 visits. If there is no bleeding from the exposed pulp, pulpectomy and root canal treatment will be performed instead, and the patient will be excluded from the study.

Also known as: Full Pulpotomy, Coronal Pulpotomy

Complete Pulpotomy

Pulpectomy and Root Canal Treatment PROCEDURE

After complete caries removal and pulp exposure, Pulpectomy will be performed to remove all pulp tissues. Conventional root canal treatment will be performed using rotary instrumentation followed by obturation with gutta percha and traditional sealers in 1 or 2 visits. A final restoration will be placed to ensure a good coronal seal, and this may include full coronal coverage restorations if clinically indicated.

Also known as: Conventional Root Canal Treatment, Non-surgical Endodontic Treatment

Pulpectomy and Root Canal Treatment

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 12 years or older
• Mature permanent tooth with deep caries/restorations
• Symptoms indicative of irreversible pulpitis (moderate to severe spontaneous lingering pain)
• Tooth is responsive to cold and electric pulp test (EPT) sensibility testing
• Tooth is restorable and can be adequately isolated during treatment
• One tooth (molar or premolar) per patient.

You may not qualify if:

• Teeth with active periodontal disease (pocket depth \>5mm)
• Teeth indicated for elective root canal treatment for restorative purposes
• Teeth with apical periodontitis
• Patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy etc.)
• Patients who are unable to consent
• History of trauma to the tooth
• Presence of apical radiolucency
• Patients who are pregnant or breast-feeding
• Teeth with any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital, Singapore

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Pulpectomy

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Victoria Yu, PhD

  National University Hosptial, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be done to the outcomes assessors to reduce bias during radiographic healing assessment. Participants also will not be informed of which treatment they are undergoing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 28, 2023
• Study Start: July 11, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 28, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)