Effectiveness of Pulpotomy vs. Root Canal Treatment in Extremely Deep Caries

Effectiveness of Pulpotomy vs. Root Canal Treatment in Extremely Deep Caries: A Randomized Controlled Trial Conducted in Supervised Undergraduate Clinics

Recent clinical trials comparing pulpotomy versus root canal treatment (RCT) have shown promising outcomes; however, the current evidence lacks generalisability to general practitioners. It remains to be elucidated whether these favourable results can be replicated in a primary care setting. This study aims to address that gap by involving senior dental students undergoing supervised university education and training, with the potential to inform future best practice guidelines and promote the adoption of vital pulp therapy (VPT) as a predictable treatment alternative in the general dental population.

The clinical procedure involves complete caries-free excavation carried out under rubber dam isolation. After confirming vital pulp status-demonstrated by bleeding upon entry, participants will be randomised to receive one of two treatments: RCT or full pulpotomy.

Outcomes will include clinical and radiographic success or failure of the intervention at 12 months. Additionally, patient-reported outcomes will be collected, specifically pain experienced and the use of analgesia during the immediate post-operative period (days 3 and 7).

Study Overview

• Status: Recruiting
• Conditions: Pulpitis; Extremely Deep Caries
• Intervention / Treatment: Procedure: Full Pulpotomy; Procedure: root canal treatment and intracanal medicament

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Yu; Phone Number: (65) 9004 1044; Email: denyshv@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • National University Centre For Oral Health Singapore (NUCOHS)
    • Contact: Victoria Yu Associate Professor; Phone Number: (65) 9004 1044; Email: denyshv@nus.edu.sg
    • Principal Investigator: Victoria Yu, PhD
    • Sub-Investigator: Angela Lin, BDS
    • Sub-Investigator: Ming Yi Tan, MDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 12 years or older
• Mature maxillary or mandibular permanent tooth with extremely deep restorations/caries penetrating the entire thickness of dentine on the radiograph without a radiopaque zone separating the lesion from the pulp (Bjorndal et al., 2019)
• Tooth may or may not be symptomatic at the time of recruitment but must be responsive to cold and EPT sensibility testing
• Tooth is restorable and can be adequately isolated during treatment
• One tooth per patient

Exclusion Criteria:

• Teeth with difficult access and unpredictable isolation using a rubber dam
• Teeth aberrant root canal morphology, extreme root curvatures (>30 degrees), calcified canals/sclerosed pulp
• Teeth indicated for elective root canal treatment for restorative purposes
• Teeth with apical periodontitis
• Presence of apical radiolucency
• Any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 1.25% hypochlorite for 10 minutes
• History of trauma to the tooth
• Teeth with active periodontal disease (pocket depth >5mm)
• Patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy etc.)
• Patients who are pregnant or breast-feeding
• Patients who are unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full Pulpotomy; The intra-operative standard care for pulpotomy is as follows: Clinical procedure should be completed over one or 2 visits; Performed under local anaesthesia and rubber dam isolation; Complete caries removal; Pulp resection using sterile high-speed bur with water coolant; Irrigation protocol with 1.25% sodium hypochlorite; Haemostasis with a 1.25% sodium hypochlorite-moistened cotton pellet over the amputated pulps for up to 10 minutes; Placement of Biodentine (Septodont Ltd., Saint Maur des Fausse s, France) or its alternative approved by NUCOHS for pulpotomy; Final definitive resin-based restoration; Post-operative periapical radiograph taken	Procedure: Full Pulpotomy; Preservation of vital pulp tissue for tooth survival.
Active Comparator: Root Canal Treatment; The intra-operative standard care for root canal treatment is as follows: Clinical procedure can be carried out over one or 2 visits; Use of rubber dam mandatory; Irrigation protocol with 1.25% sodium hypochlorite; Working length with combined radiographs and apex locators; Automated instrumentation to accompany hand instrumentation; Preparation to apical size 2-3 larger than largest file that binds at the WL in the uninstrumented canal initial apical file (IAF); Canal medicament; non setting calcium hydroxide if done in two visits; Root canal filling with gutta pecha and traditional sealers (cold lateral or warm vertical condensation); Ensure coronal seal; Good quality postoperative radiograph using parallel cone technique; Final restoration as per undergraduate clinical protocols	Procedure: root canal treatment and intracanal medicament; Root canal treatment as a comparator to pulpotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	Clinical and radiographic success or failure of the intervention will be measured at 12 months. The primary outcome is a composite measure at 12 months: 1) absence of pain indicative of unhealthy pulp; 2) absence of signs and symptoms indicative of acute or chronic periapical disease; 3) absence of radiographic evidence of failure including radiolucency or resorption. Failure of any part of the composite, at or any time before 12 months, will equate to overall treatment failure.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome	A patient reported outcome of pain experienced and use of analgesia in the immediate post-operative period (days 3, 7) will be collected through a paper questionnaire distributed at visit 1. The presence of a structurally integral tooth with an intact, nondefective restoration at 12 months, with positive sensibility response to EPT and with absence of need for any further intervention during the 12-month follow-up period, presence of calcification or adverse event will be reported on. A parallel health economics analysis will be completed using data collected from participants at baseline and at 12 months using common agreed templates.	12 months

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Pulpitis
• Other Study ID Numbers: 2024-4505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only anonymised data can be shared, subject to local health records governance.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No