Extremely Deep Caries, Pulpitis
Conditions
Brief summary
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
PROCEDUREFull Pulpotomy
Preservation of vital pulp tissue for tooth survival.
Root canal treatment as a comparator to pulpotomy.
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
care providers and participants are masked at the start of caries removal and up to the stage of random allocation to pulpotomy or root canal treatment.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome | 12 months | 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. |
Countries
Singapore
Contacts
Primary ContactVictoria Yu
Outcome results
None listed