Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
NCT ID: NCT05964933
Last Updated: 2023-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
70 participants
INTERVENTIONAL
2023-07-11
2027-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Complete Pulpotomy
The tooth will be treated with Complete Pulpotomy.
Complete Pulpotomy
Complete caries removal and excision of the entire coronal pulp to the level of the root canal orifices will be performed. After haemostasis, the pulp chamber will be filled with Biodentine® and a final direct restoration placed in 1 or 2 visits.
If there is no bleeding from the exposed pulp, pulpectomy and root canal treatment will be performed instead, and the patient will be excluded from the study.
Pulpectomy and Root Canal Treatment
The tooth will be treated with Pulpectomy and Root Canal Treatment.
Pulpectomy and Root Canal Treatment
After complete caries removal and pulp exposure, Pulpectomy will be performed to remove all pulp tissues. Conventional root canal treatment will be performed using rotary instrumentation followed by obturation with gutta percha and traditional sealers in 1 or 2 visits. A final restoration will be placed to ensure a good coronal seal, and this may include full coronal coverage restorations if clinically indicated.
Interventions
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Complete Pulpotomy
Complete caries removal and excision of the entire coronal pulp to the level of the root canal orifices will be performed. After haemostasis, the pulp chamber will be filled with Biodentine® and a final direct restoration placed in 1 or 2 visits.
If there is no bleeding from the exposed pulp, pulpectomy and root canal treatment will be performed instead, and the patient will be excluded from the study.
Pulpectomy and Root Canal Treatment
After complete caries removal and pulp exposure, Pulpectomy will be performed to remove all pulp tissues. Conventional root canal treatment will be performed using rotary instrumentation followed by obturation with gutta percha and traditional sealers in 1 or 2 visits. A final restoration will be placed to ensure a good coronal seal, and this may include full coronal coverage restorations if clinically indicated.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
12 Years
ALL
Yes
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Victoria Yu, PhD
Role: PRINCIPAL_INVESTIGATOR
National University Hosptial, Singapore
Locations
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National University Hospital, Singapore
Singapore, , Singapore
Countries
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Other Identifiers
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DSRB 2023/00044
Identifier Type: -
Identifier Source: org_study_id