Comparison of 3Mixtatin Pulpotomy and Metapex Pulpectomy in Primary Molars With Irreversible Pulpitis

NCT06925490 | Not Yet Recruiting Phase 1

• 1 other identifier: 3Mixtatin and Metapex pulpitis
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study aims to evaluate the clinical and radiographic success of pulpotomy using 3Mixtatin versus pulpectomy using Metapex in primary molars with irreversible pulpitis in children aged 4 to 9 years.

Conditions

Irreversible Pulpitis; Primary Teeth; Pulp Disease, Dental

Keywords

3Mixtatin; irreversible pulpitis; metapex; pulpectomy; pulpotomy

Outcome Measures

Primary Outcomes (1)

• Clinical success

  * Pain to percussion will be assessed by applying a light-tapping force to the relevant tooth using the blunt end of the dental probe. Tapping will be applied as gently as possible from a 1 cm distance, either present or absent. * Swelling will be assessed through clinical examination, either present or absent. * The sinus tract or fistula will be assessed through clinical examination, either present or absent. * The mobility of teeth will be assessed by applying pressure to the ends of two metal instruments, either present or absent. * The principal investigator and the co-supervisor will undertake this clinical assessment on every recall visit during the 3, 6, 9, and 12 months follow-up period.

  3, 6, 9, and 12 months follow-up period

Secondary Outcomes (2)

• Radiographic Success

  6 and 12 months

• Post operative pain

  1 week, 3, 6, 9, and 12 months.

Study Arms (2)

metapex pulpectomy

ACTIVE COMPARATOR

Single-visit pulpectomy using Metapex, . Calcium hydroxide-iodoform mixture (Metapex) is an ideal pulpal filling material for primary teeth.

Drug: Metapex

3Mixtatin Pulpotomy

EXPERIMENTAL

pulpotomy with 3 mixtatin (triple antibiotic paste of (Metronidazole, cefixime, and Ciprofloxacin mixed with simvastatin ) applied in the vital pulp therapy

Drug: 3Mixtatin

Interventions

Metapex DRUG

Pulpectomy using Metapex

metapex pulpectomy

3Mixtatin DRUG

pulpotomy treatment when applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin

3Mixtatin Pulpotomy

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged from 4 to 9 years with vital primary molars showing signs of irreversible pulpitis.
• 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 eight minutes of compression using a cotton pellet with 5% sodium hypochlorite.
• Absence of peri-apical or inter-radicular radiolucency, widening of periodontal ligament space, internal or external root resorption.

You may not qualify if:

• Unrestorable primary molars.
• Primary molars with uncontrolled pulp hemorrhage or pulp necrosis.
• Medically compromised patients who have systemic disease.
• Uncooperative children who refuse treatment.
• Children whose parents are unwilling to place stainless steel crowns.
• Children whose parents or caregivers refuse to participate in the study or are unable to attend follow-up visits.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Metapex

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Osama Ibrahim El Shahawy, Professor

  Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

• Marwa Aly Fouad, Associate professor

  Associate Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

  STUDY CHAIR

Central Study Contacts

Nora Mohamed Mosaad, PHD researcher

CONTACT

00201000921189; nora.mosaad@dentistry.cu.edu.eg

Marwa Aly Fouad, Associate Professor

CONTACT

marwaaly2003@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pedodontist, Cairo University

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share