Actively Recruiting

Phase Not Applicable
Age: 12Years +
All Genders
ID07242742

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

Led by National University Hospital, Singapore · Updated on 2025-11-21

93

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of two dental treatments, full pulpotomy and root canal treatment, for patients with extremely deep caries affecting permanent teeth. This randomized controlled trial is conducted in supervised undergraduate dental clinics and aims to determine if the promising results seen in previous trials can be replicated when treatments are performed by senior dental students. The study focuses on preserving vital pulp tissue as a potential alternative to root canal treatment, which may influence future dental care guidelines. Participants will undergo a clinical procedure that includes complete removal of decay under rubber dam isolation. After confirming the tooth's vital pulp status by observing bleeding, they will be randomly assigned to receive either full pulpotomy or root canal treatment. Both procedures may be completed over one or two visits, involve local anesthesia, and follow detailed protocols including specific irrigation and restoration techniques. Full pulpotomy uses materials like Biodentine to preserve pulp, while root canal treatment includes canal cleaning, filling, and sealing. During the study, participants will be assessed through clinical and radiographic examinations at 12 months to evaluate treatment success or failure. Patient-reported outcomes such as pain and analgesic use will be collected in the first week after treatment. The study includes post-operative radiographs and follow-ups to monitor healing and tooth survival, with all procedures carried out under supervised training conditions to reflect real-world dental practice.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 12 years or older
  • Mature permanent maxillary or mandibular tooth with extremely deep caries penetrating the entire thickness of dentine on radiograph without a radiopaque zone separating the lesion from the pulp
  • Tooth may be symptomatic or not but must respond to cold and electric pulp testing
  • Tooth is restorable and can be adequately isolated during treatment
  • Only one tooth per patient
Not Eligible

You will not qualify if you...

  • Teeth with difficult access and unpredictable isolation using a rubber dam
  • Teeth with abnormal root canal shape, extreme root curvature over 30 degrees, or calcified canals
  • Teeth planned for elective root canal treatment for restoration purposes
  • Teeth with apical periodontitis or apical radiolucency
  • Teeth showing purulence or excessive bleeding uncontrolled by 1.25% hypochlorite for 10 minutes
  • History of trauma to the tooth
  • Teeth with active periodontal disease with pocket depth over 5mm
  • Patients with complex medical conditions affecting healing such as immunocompromise or radiotherapy
  • Patients who are pregnant or breastfeeding
  • Patients unable to consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 to 2 visits over a few days

Participants receive either full pulpotomy or root canal treatment to manage extremely deep caries in a vital tooth.

1 to 2 visits (in-person)

Follow-up

Duration - 12 months

Participants attend follow-up visits to monitor tooth health and treatment success over 12 months.

Visits as scheduled during 12-month follow-up

Trial Site Locations

Total: 1 location

1

National University Centre For Oral Health Singapore (NUCOHS)

Singapore, Singapore

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Research Team

V

Victoria Yu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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