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

NCT06002698 | Unknown

• 1 other identifier: DF RD2309/0068 (L)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 2.Undertake a cost-effectiveness analysis to examine the potential long-term costs and benefits of pulpotomy.
3. 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.

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Post-operative pain

  Day 3 and Day 7

• Structural integrity assessment

  6 months, 1 year and 2 years

• Evidence of further interventions and adverse effects

  6 months, 1 year and 2 years

• Data for cost effective analysis

  Baseline, 6 months, 1 year and 2 years

Study Arms (2)

Root canal treatment (Control)

OTHER

The procedure can be carried out in single or two visits. Variations in root canal treatment protocols however will make it difficult to compare with pulpotomy so the aim is to standardize the protocols for the following variables including use of rubber dam, Irrigation protocol with 2-2.5% sodium hypochlorite; working length with combined radiographs and apex locators, automated instrumentation to accompany hand instrumentation and preparation to apical size 2-3 larger than the initial binding file. Canal to be medicated with non-setting calcium hydroxide if done in two visits and root canal filling with gutta percha and traditional sealers (warm or cold lateral condensation) and good coronal seal.

Procedure: Root canal treatment (Control)

Full pulpotomy

EXPERIMENTAL

The clinical procedure will be completed over one or two visits. Following adequate anesthesia and isolation with rubber dam, access to the pulp will be gained following caries removal to de-roof the pulp chamber and excision of the entire coronal pulp. The pulp chamber is irrigated with 2% sodium hypochlorite solution and the resultant bleeding from the remaining pulp will be controlled with a cotton pellet soaked in 2% sodium hypochlorite solution. Following complete haemostasis, the pulp stump will then be covered with Biodentine (Septodont Ltd., Saint Maur des Fausse ́s, France) and the tooth permanently restored with a restoration if treatment is completed in single visit or temporized with glass ionomer cement for the final restoration to be placed in the 2nd visit if operator opted for 2-visit treatment.

Procedure: Full pulpotomy (Experimental)

Interventions

Root canal treatment (Control) PROCEDURE

Root canal treatment - Removal of the inflamed pulp tissues from the whole root canals of the tooth.

Root canal treatment (Control)

Full pulpotomy (Experimental) PROCEDURE

Full pulpotomy - Removal of the inflamed coronal pulp tissues from the crown of the tooth.

Full pulpotomy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Hany Mohamed Aly Ahmed

Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (3)

• 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.

  PMID: 30664240 BACKGROUND

• 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.

  PMID: 34352305 BACKGROUND

• 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.

  PMID: 37080387 BACKGROUND

Study Officials

• Hany Ahmed, PhD

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany Ahmed, PhD

CONTACT

0060129857937; hanyendodontist@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 21, 2023
• Study Start: August 8, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)