Pulpotomy versus root canal treatment for extremely deep caries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pulpal inflammation and full pulpotomy outcomes in deeply carious mandibular molars

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• Partial pulpotomy in mature lower molars with SIP using calcium hypochlorite vs sodium hypochlorite

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• Direct pulp capping for deep and extremely deep caries in mature molars with reversible pulpitis

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  Recruiting Postgraduate Institute of Dental Sciences Rohtak · Rohtak, Haryana · NCT07696702

• Buffered vs conventional local anesthesia for pain and anxiety during dental treatment in children with pulpitis

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• Direct pulp capping in lower molars with side (proximal) versus top (occlusal) cavities: does the cavity location matter?

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  Recruiting Postgraduate Institute of Dental Sciences Rohtak · Rohtak, Haryana · NCT07578662

• Using pulpal blood biomarkers to predict success of vital pulp therapy in symptomatic teeth

  This trial will test whether measuring metabolic biomarkers in pulpal blood at the time of carious pulp exposure can help predict 12-month success of vital pulp treatment in people aged 16–50 with symptomatic deep caries.

  Recruiting University of Baghdad · Baghdad · NCT07452614

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.