Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

Pulpitis - Irreversible Clinical Trial

Official title:

Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002698
• Other study ID #: DF RD2309/0068 (L)
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: University of Malaya
• Contact: Hany Ahmed, PhD
• Phone: 0060129857937
• Email: hanyendodontist[@]um.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Procedure:
• Root canal treatment (Control)
Root canal treatment - Removal of the inflamed pulp tissues from the whole root canals of the tooth.
• Full pulpotomy (Experimental)
Full pulpotomy - Removal of the inflamed coronal pulp tissues from the crown of the tooth.

Locations

Country	Name	City	State
Malaysia	Hany Mohamed Aly Ahmed	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical 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.	6 months, 1 year and 2 years
Primary	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.	6 months, 1 year and 2 years
Secondary	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.	Day 3 and Day 7
Secondary	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	6 months, 1 year and 2 years
Secondary	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.	6 months, 1 year and 2 years
Secondary	Data for cost effective analysis	Data for cost effective analysis and process evaluation will be collected.	Baseline, 6 months, 1 year and 2 years