Clinical trial NCT05964933: Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
Official title: Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: dental caries
deep caries
pulpotomy
root canal treatment
vital pulp therapy
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.
Primary purpose: TREATMENT

Brief summary: This study is a randomised controlled trial for complete pulpotomy as an alternative to root canal treatment for teeth with clinical diagnosis of symptomatic irreversible pulpitis (i.e. signs and symptoms indicative of irreversible pulpitis) conducted at the National University Centre for Oral Health Singapore (NUCOHS) Endodontic unit. Up to 70 teeth, 35 in each group, will be enrolled.

Clinical and radiographic outcome data will be collected and analysed, and a parallel cost-effectiveness analysis will also be undertaken to examine the potential costs and benefits of pulpotomy. A process evaluation will also be conducted to assess the acceptability of the intervention to both dentists and patients, while exploring the barriers and enablers to implementation.

Detailed description: Mature permanent teeth with deep caries/restorations and symptoms indicative of irreversible pulpitis (moderate to severe spontaneous lingering pain) will be included in the study. The teeth will be randomised to receive one of two treatments: RCT or complete pulpotomy (n=35 in each group).

Baseline clinical and radiographic data will be collected at the first visit. In addition, patients (or their guardians, if relevant) will be invited to complete the acceptability and willingness to pay questionnaires for health economics analysis at both the first visit and at 12 months from the date of completed treatment. Pain data will be collected via a pain diary after completion of treatment at days 3 and 7 post-treatment. Patients will be clinically and radiographically reviewed at 6 and 12 months from the date of completed treatment. Review clinical data collected will include the absence of pain (and details on the nature of pain, if relevant), tenderness to percussion and palpation, presence of a swelling or a sinus tract, pathological mobility, structural integrity of tooth, intact and non-defective restoration, and response to electric pulp testing (for the pulpotomy group only). Radiographic data collected will include the presence of periapical radiolucency, presence of inter-radicular radiolucency, presence of resorption, and presence of calcifications. The need for any further intervention (including details of any procedure) or any adverse events or unscheduled visits over the follow-up period will also be recorded.

Success will be defined as 1) the absence of pain indicative of irreversible pulpitis, 2) the absence of signs and symptoms indicative of acute or chronic periapical disease, and 3) the absence of radiographic evidence of failure including radiolucency or resorption. SPSS Statistical Package (IBM SPSS Statistics) will be used for all statistical analysis, with the significance level for all statistical tests set at p-value\<0.05.

Eligibility criteria: Inclusion Criteria:

* Patients aged 12 years or older
* Mature permanent tooth with deep caries/restorations
* Symptoms indicative of irreversible pulpitis (moderate to severe spontaneous lingering pain)
* Tooth is responsive to cold and electric pulp test (EPT) sensibility testing
* Tooth is restorable and can be adequately isolated during treatment
* One tooth (molar or premolar) per patient.

Exclusion Criteria:

* Teeth with active periodontal disease (pocket depth \>5mm)
* Teeth indicated for elective root canal treatment for restorative purposes
* Teeth with apical periodontitis
* Patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy etc.)
* Patients who are unable to consent
* History of trauma to the tooth
* Presence of apical radiolucency
* Patients who are pregnant or breast-feeding
* Teeth with any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes

Primary outcomes:
measure: Composite measure is defined by the change from baseline pain and radiographic status at 6 months and again at 12 months.
timeFrame: 6, 12 months
Secondary outcomes:
measure: Numeric Rate Scale (NRS): minimum value = 0 (best outcome), maximum value = 10 (worst outcome)
timeFrame: 3, 7 days
measure: Restoration: the restoration remains intact and adapts completely to the prepared cavity margins.
timeFrame: 6, 12 months
measure: A "yes" or "no" response when the Cold Test and Electric Pulp Test are applied on the treated tooth.
timeFrame: 6, 12 months
measure: N5. Clinicians examine the treated tooth to determine if there is pathology that resulted from the treatment.
timeFrame: 12 months
measure: Data to be collected include time spent on receiving the treatment, cost of treatment, and patients' willingness to pay for treatment.
timeFrame: 12 months
measure: Radiographic appearance of the dental pulp and its canal(s) at baseline will be compared to that at 12 months.
timeFrame: 12, months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
Study officials:
affiliation: National University Hosptial, Singapore
name: Victoria Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References: