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Recruiting NCT07242742

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

No phase Interventional Extremely Deep Caries Pulpitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Full Pulpotomy, root canal treatment and intracanal medicament.
Who it may be relevant to
Registry conditions: Extremely Deep Caries, Pulpitis. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Procedure Full Pulpotomy
    Preservation of vital pulp tissue for tooth survival.
  • Procedure root canal treatment and intracanal medicament
    Root canal treatment as a comparator to pulpotomy.

Primary outcome measures

  • Primary Outcome [Time frame: 12 months]
Secondary outcome measures (1)
  • Secondary Outcome [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Singapore · 1 center
  • National University Centre For Oral Health Singapore (NUCOHS) — Singapore

Identifiers

NCT: NCT07242742 · 2024-4505

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗