Clinical trial NCT06002698: Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
Official title: Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulpitis - Irreversible
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Data
timeFrame: 6 months, 1 year and 2 years
measure: Radiographic data
timeFrame: 6 months, 1 year and 2 years
Secondary outcomes:
measure: Post-operative pain
timeFrame: Day 3 and Day 7
measure: Structural integrity assessment
timeFrame: 6 months, 1 year and 2 years
measure: Evidence of further interventions and adverse effects
timeFrame: 6 months, 1 year and 2 years
measure: Data for cost effective analysis
timeFrame: Baseline, 6 months, 1 year and 2 years
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Hany Mohamed Aly Ahmed
Study officials:
affiliation: University of Malaya
name: Hany Ahmed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
citation: AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available.
citation: Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.