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

Last updated: August 15, 2023
Sponsor: University of Malaya
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute And Chronic Dental Pain

Treatment

Full pulpotomy (Experimental)

Root canal treatment (Control)

Clinical Study ID

NCT06002698
DF RD2309/0068 (L)
  • Ages > 12
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Patients aged 12 years or older (with a mature permanent tooth demonstratingradiographic evidence of a deep caries/restorations and signs/ symptoms indicative ofIRP (moderate to severe spontaneous lingering pain). Tooth will be responsive to coldand EPT sensibility testing, restorable and can be adequately isolated duringtreatment. One posterior tooth (molar or premolar) only per patient.

Exclusion

Exclusion Criteria:

  • Teeth with active periodontal disease (pocket depth >5mm); teeth indicated forelective root canal treatment for restorative purposes, teeth with apicalperiodontitis, patients with complex medical histories that may affect their cariesexperience and healing ability (immunocompromised, radiotherapy), patients who areunable to consent; history of previous trauma to the tooth, presence of apicalradiolucency and patients who are pregnant or breast-feeding. Intraoperatively, anyevidence of purulence or excessive bleeding that cannot be controlled with a cottonpellet with 2-4% hypochlorite for 10 minutes will be excluded.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Full pulpotomy (Experimental)
Phase:
Study Start date:
August 08, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Hany Mohamed Aly Ahmed

    Kuala Lumpur, 50603
    Malaysia

    Active - Recruiting

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