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

NCT06751316 | Not Yet Recruiting

• 1 other identifier: Pulpotomy Versus Pulpectomy
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Decayed Primary Molars With Irreversible Pulpitis

Keywords

MTA pulpotomy; Pulpectomy; Decayed primary molars; Irreversible pulpitits

Outcome Measures

Primary Outcomes (1)

• • rate of clinical success

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

  12 months

Secondary Outcomes (1)

• • rate of radiographic success

  12 months

Study Arms (2)

Conventional Pulpectomy

EXPERIMENTAL

Conventional pulpectomy using Zinc Oxide/Eugenol

Procedure: Conventional Pulpectomy

MTA Pulpotomy

EXPERIMENTAL

Pulpotomy using MTA

Procedure: MTA Pulpotomy

Interventions

Conventional Pulpectomy PROCEDURE

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

Conventional Pulpectomy

MTA Pulpotomy PROCEDURE

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

MTA Pulpotomy

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

EG (1)