Pulpotomy versus root canal treatment for extremely deep caries
Effectiveness of Pulpotomy vs. Root Canal Treatment in Extremely Deep Caries: A Randomized Controlled Trial Conducted in Supervised Undergraduate Clinics
This study tests whether full pulpotomy works as well as root canal treatment for people aged 12 and older with extremely deep caries treated in a university dental clinic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 93 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07242742 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial will enroll patients with mature permanent teeth and extremely deep caries whose pulps are confirmed vital by bleeding on entry. After complete caries excavation under rubber dam isolation, eligible teeth are randomized to receive either full pulpotomy or conventional root canal treatment performed by senior dental students under supervision. Primary outcomes are clinical and radiographic success or failure at 12 months, with standardized follow-up visits and imaging; patient‑reported outcomes will also be recorded. The aim is to see if favorable pulpotomy results seen in specialist centers can be replicated in a primary care/teaching clinic setting to inform broader practice.
Who should consider this trial
Good fit: Ideal candidates are people aged 12 or older with a mature permanent tooth with extremely deep caries that is restorable, responds to sensibility testing, and can be isolated with a rubber dam.
Not a fit: Patients with non‑vital teeth, apical periodontitis or radiolucency, uncontrolled purulence or excessive bleeding, calcified or highly aberrant canal anatomy, or teeth that cannot be adequately isolated are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the trial could offer patients a less invasive, faster, and tooth‑preserving alternative to root canal treatment that is feasible in general dental practice.
How similar studies have performed: Previous trials in specialist settings have reported promising outcomes for pulpotomy versus RCT, but those results have limited generalizability to general dental practice.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Singapore
- National University Centre For Oral Health Singapore (NUCOHS) — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Victoria Yu
- Email: denyshv@nus.edu.sg
- Phone: (65) 9004 1044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.