Pulpitis - Irreversible
Conditions
Brief summary
Background The European Society of Endodontology (ESE) and the American Association of Endodontists (AAE) position statements on the management of deep caries and exposed pulp recommended adoption and promotion of strategies aimed at preserving the pulp, but also acknowledged the need for well-designed and adequately powered randomised control trials to provide the evidence needed to support vital pulp treatment (VPT) and change clinical practice. Objectives 1. To undertake a randomised controlled clinical trial comparing full pulpotomy with root canal treatment for mature maxillary and mandibular posterior teeth with signs and symptoms indicative of irreversible pulpitis and normal apical tissues in adults. 2. Undertake a cost-effectiveness analysis to examine the potential long-term costs and benefits of pulpotomy. 3. Undertake a process evaluation to assess the acceptability of the intervention to both dentists and patients, while exploring the barriers and enablers to implementation.
Interventions
PROCEDURERoot canal treatment (Control)
Root canal treatment - Removal of the inflamed pulp tissues from the whole root canals of the tooth.
PROCEDUREFull pulpotomy (Experimental)
Full pulpotomy - Removal of the inflamed coronal pulp tissues from the crown of the tooth.
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 12 years or older (with a mature permanent tooth demonstrating radiographic evidence of a deep caries/restorations and signs/ symptoms indicative of IRP (moderate to severe spontaneous lingering pain). Tooth will be responsive to cold and EPT sensibility testing, restorable and can be adequately isolated during treatment. One posterior tooth (molar or premolar) only 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), patients who are unable to consent; history of previous trauma to the tooth, presence of apical radiolucency and patients who are pregnant or breast-feeding. Intraoperatively, any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Data | 6 months, 1 year and 2 years | (1) Clinical data: absence of pain, tenderness to palpation, presence of swelling, presence of sinus tract, pathological mobility, response to sensibility testing. Patient history taking and clinical examination for symptoms and clinical signs of infection such as swelling, and sinus tract will be performed by a blinded dental practitioner. |
| Radiographic data | 6 months, 1 year and 2 years | (2) Radiographic data: presence of periapical radiolucency, presence of inter-radicular radiolucency, presence of resorption, presence of calcifications. An independent assessor will assess the radiograph obtained at the 12-month review visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | Day 3 and Day 7 | (1) Postoperative pain will be recorded by patients on day 3 and 7. Pain will be assessed using a numeric rating scale (NRS). NRS is an 11-point numeric scale with 0 representing no pain and 10 representing pain as bad as you can imagine. Patients will be instructed on how to use the NRS-11 at home on days 3 and 7 after the procedure. Patients will be contacted by phone call or text message to collect their responses. |
| Structural integrity assessment | 6 months, 1 year and 2 years | (2) Structural integrity of the tooth will be assessed by a blinded dental practitioner at the 12-month visit using World Dental Federation (FDI) criteria |
| Evidence of further interventions and adverse effects | 6 months, 1 year and 2 years | Evidence of further interventions and adverse events will be obtained from patient records following the 12-month review visit. |
| Data for cost effective analysis | Baseline, 6 months, 1 year and 2 years | Data for cost effective analysis and process evaluation will be collected. |
Countries
Malaysia
Contacts
Primary ContactHany Ahmed, PhD
Outcome results
None listed