Effectiveness of Pulpotomy vs. Root Canal Treatment in Extremely Deep Caries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorNational University Hospital, Singapore
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Full Pulpotomy
Procedure/SurgeryPreservation of vital pulp tissue for tooth survival.
root canal treatment and intracanal medicament
Procedure/SurgeryRoot canal treatment as a comparator to pulpotomy.
Treatment groups
93 Participants
are divided into 2 treatment groupsGroup A: Full PulpotomyExperimental treatment 1 intervention
Group B: Root Canal TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome
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.
Time frame
12 monthsSecondary outcomes
1
Secondary Outcome
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.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov