Treatment outcomes of pulpotomy versus pulpectomy in vital primary molars diagnosed with symptomatic irreversible pulpitis: protocol for a non-inferiority randomised controlled trial

Treatment Outcomes of Pulpotomy vs. Pulpectomy in Vital Primary Molars with Irreversible Pulpitis

Background

Pulpectomy has been the traditional treatment for vital primary molars with irreversible pulpitis. However, recent advancements suggest that pulpotomy, a more conservative approach, could be effective. This trial aims to compare the effectiveness of pulpotomy versus pulpectomy in managing symptomatic irreversible pulpitis in vital primary molars over a two-year period.

Methods/Design

This clinical study is a two-armed, non-inferiority randomized controlled trial. Children aged 4-9 with painful primary molars showing symptoms of irreversible pulpitis will be recruited. 50 vital primary molars will be randomly assigned to either pulpotomy or pulpectomy. Primary outcomes will include clinical and radiographic success over six months, one year, and two years. The trial will also assess the impact of pre-operative and intra-operative factors on treatment outcomes. Secondary outcomes will evaluate immediate post-operative pain relief.

Discussion

This trial aims to provide evidence on whether pulpotomy can be as effective as pulpectomy for managing symptomatic irreversible pulpitis in vital primary molars.

Trial Registration

ClinicalTrials.gov (NCT06183203). Registered on 30 January 2024.

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