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Not yet recruiting NCT06922578

Clinical and Radiographic Success of Pulpotomy Using Neoputty Mineral Trioxide Aggregate Versus Pulpectomy Using Endoflas In Primary Molars With Irreversible Pulpitis: A Randomized Controlled Trial

No phase Interventional Pulpitis - Irreversible

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NeoPUTTY MTA pulpotomy, Endoflas pulpectomy.
Who it may be relevant to
Registry conditions: Pulpitis - Irreversible. Basic parameters: 4 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this randomized clinical trial is to evaluate the clinical and radiographic success of pulpotomy using Neoputty MTA vital primary molars diagnosed with symptomatic irreversible pulpitis. The main question it aims to answer is: Will Neoputty MTA pulpotomy have higher clinical and radiographic success in comparison to Endoflas pulpectomy in primary molars with irreversible pulpitis?

Interventions

  • Procedure NeoPUTTY MTA pulpotomy
    Neoputty MTA pulpotomy performed in vital primary molars with symptomatic irreversible pulpitis
  • Procedure Endoflas pulpectomy
    Endoflas pulpectomy in vital primary molars with symptomatic irreversible pulpitis

Primary outcome measures

  • postoperative pain [Time frame: within 24 hours, after 1 week, 3, 6, 9, and 12 months]

Eligibility criteria

Inclusion criteria

  • Children with spontaneous pain lasting a few seconds to several hours.
  • Pain is intensified by thermal stimulus and persists after its removal.
  • Pulp hemorrhage after performing access cavity and deroofing of pulp chamber showing reddish pink healthy pulp tissue.
  • Radicular pulp health is verified by achieving hemostasis within six minutes of compression using a cotton pellet with 2% sodium hypochlorite.
  • Absence of peri-apical or inter-radicular radiolucency, widening of periodontal ligament space, internal or external root resorption.

Exclusion criteria

  • Unrestorable primary molars.
  • Primary molars with uncontrolled pulp hemorrhage or pulp necrosis.
  • Medically compromised patients who have systemic disease.
  • Uncooperative children who refuse treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06922578 · Neoputty MTA pulpotomy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗