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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Root canal treatment - Removal of the inflamed pulp tissues from the whole root canals of the tooth.
Full pulpotomy - Removal of the inflamed coronal pulp tissues from the crown of the tooth.
Hany Mohamed Aly Ahmed
Kuala Lumpur, Malaysia
RECRUITINGClinical Data
(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.
Time frame: 6 months, 1 year and 2 years
Radiographic data
(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.
Time frame: 6 months, 1 year and 2 years
Post-operative pain
(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.
Time frame: Day 3 and Day 7
Structural integrity assessment
(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
Time frame: 6 months, 1 year and 2 years
Evidence of further interventions and adverse effects
Evidence of further interventions and adverse events will be obtained from patient records following the 12-month review visit.
Time frame: 6 months, 1 year and 2 years
Data for cost effective analysis
Data for cost effective analysis and process evaluation will be collected.
Time frame: Baseline, 6 months, 1 year and 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.