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Biodentine Pulpotomy vs Metapex Pulpectomy in Primary Molars: Clinical & Radiographic Comparison of Outcomes in Irreversible Pulpitis Cases

NCT06524921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-03-24

No results posted yet for this study

Summary

Irreversible pulpitis is defined as a clinical diagnostic based on subjective and objective findings suggesting that the vital inflamed pulp is incapable of healing in the American Association of Endodontists (AAE) Consensus Conference Recommended Diagnostic Terminology. Other characteristics include persistent heat discomfort, transferred pain, spontaneous pain, or no clinical symptoms but caries-induced inflammation, caries excavation, and trauma.".

Dental caries is one of the most frequently occurring diseases affecting human beings that becomes a challenge for dentists as the disease progresses. The ultimate goal of operative and endodontic treatment is to preserve and maintain the vitality of pulp to allow continued development of odontogenic apparatus.

Conditions

  • Dental Caries

Interventions

PROCEDURE

dental pulpectomy using metapex

Metapex: A dental pulpectomy treats tooth with irreversible pulpitis in primary and teeth by removing infected pulp tissue using files and irrigation in the radicular part. The procedure involves anesthesia, decay removal, pulp chamber access, filing and irrigation till we reach cleaned dried canals and applying a medicament like Metapex . The tooth is then restored with a filling, often a stainless steel crown. The loss of pulp tissue weakens the tooth's structure and increases the risk of fracture and infection.

PROCEDURE

dental pulpotomy using biodentine

Biodentine: A dental pulpotomy treats tooth decay or trauma in primary and young permanent teeth by removing infected pulp tissue in the crown while preserving healthy root pulp. The procedure involves anesthesia, decay removal, pulp chamber access, hemostasis, and applying a medicament like MTA or Biodentine. The tooth is then restored with a filling, often a stainless steel crown. Pulpotomies preserve tooth structure, relieve pain, and are less invasive than full root canals, but require regular follow-up.

Sponsors & Collaborators

  • Mohamed Ahmed Hamdi Abo El Yamin

    lead OTHER

Principal Investigators

  • Marwa Salamoon, Ph.D · Lecturer of Pediatric Dentistry and Dental Public Health MSA University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-09-01
Completion
2025-09-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524921 on ClinicalTrials.gov