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NCT Number: NCT06751316

Clinical and Radiographic Evaluation of MTA Pulpotomy Versus Conventional Pulpectomy in Primary Molars With Irreversible Pulpitis

This study is designed to compare between MTA Pulpotomy (Removal of coronal pulp tissue, placing MTA and covering with Stainless steel crown) Versus Conventional Pulpectomy (Removal of radicular pulp tissue, placing Zinc Oxide/Eugenol and covering with Stainless steel crown) in irreversible pulpitis in primary second molars.

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients:
  • Aged 4-7 years, cooperative, in good general health and medically within normal
  • Teeth:
  • Restorable mandibular second primary molars.
  • History of irreversible pulpitis.
  • Preoperative radiograph:
  • Absence of periapical or inter-radicular radiolucency.
  • Absence of widening of periodontal ligaments (PDL) space.
  • Absence of internal or external root resorption.

Exclusion criteria

  • Patients:
  • With systemic disorders.
  • Physical or mental disabilities.
  • Unable to attend follow- up visits.
  • Refusal of Participation.
  • Refusal to sign the informed consent.
  • Teeth:
  • Previously accessed teeth.
  • Mobile mandibular second primary molar.
  • Swelling in the vestibule or on palpation.
  • Pain on percussion.

Treatment and study plan

Conventional pulpectomy

Procedure

Removal of radicular pulp tissue, placing Zinc Oxide/Eugenol and covered by stainless steel crown

MTA Pulpotomy

Procedure

Removal of coronal pulp tissue, placing MTA and covered by stainless steel crown

Primary outcomes

  1. • rate of clinical success

    Time frame: 12 months

    • tenderness on percussion and palpation
    • sinus/parulis/fistula
    • soft tissue swelling
    • pathological mobility

Secondary outcomes

  1. • rate of radiographic success

    Time frame: 12 months

    • pathologic root resorption.
    • interradicular and/or periapical radiolucency

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of MTA Pulpotomy Versus Conventional Pulpectomy in Primary Molars With Irreversible Pulpitis: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

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.