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NCT Number: 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

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?

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Key information

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NeoPUTTY MTA pulpotomy

Procedure

Neoputty MTA pulpotomy performed in vital primary molars with symptomatic irreversible pulpitis

Endoflas pulpectomy

Procedure

Endoflas pulpectomy in vital primary molars with symptomatic irreversible pulpitis

Primary outcomes

  1. postoperative pain

    Time frame: within 24 hours, after 1 week, 3, 6, 9, and 12 months

    postoperative pain will be assessed using the visual analogue scale (VAS) within 24 hours, after 1 week, 3, 6, 9, and 12 months. The patients are asked to point to the face that best represents how they are feeling at the follow-up visits.

Study contacts

Contact information is provided by the study sponsor or research team.

manar motawie el nimr, masters

CONTACT

[email protected]

0201101778899

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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