MedTrace Logo

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

NCT06002698 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-21

No results posted yet for this 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.

Conditions

  • Pulpitis - Irreversible

Interventions

PROCEDURE

Root canal treatment (Control)

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

PROCEDURE

Full pulpotomy (Experimental)

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

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Hany Ahmed, PhD · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-08
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • Malaysia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002698 on ClinicalTrials.gov