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

NCT ID: NCT06925490

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-10-31

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.

Detailed Description

Primary teeth play an essential role in esthetics, phonatics, and mastication, that's why they should be preserved as the best space maintainers until their proper exfoliation time. Various pulp therapies were suggested based on the extent of carries, including vital pulp therapy (direct pulp capping, pulpotomy) and non-vital pulp therapy (pulpectomy). Current guidelines from the American Academy of Pediatric Dentistry (AAPD) and the British Society of Paediatric Dentistry (BSPD) recommend pulpectomy as the gold standard treatment for vital primary molars diagnosed with irreversible pulpitis. Pulpectomy is a non-vital treatment procedure where the entire pulp tissue is extirpated and the root canals debrided and shaped to receive a resorbable material to fill the canal space in the affected primary tooth.

In recent years, a paradigm shift has emerged towards performing pulpotomy, a more conservative approach that involves partial removal of the pulp tissue, furthermore, a previous histological study of teeth with irreversible pulpitis showed that inflammation and microbial invasion are confined to the coronal pulp, sparing the radicular pulp. This finding concurred that pulpotomy could represent a viable treatment option for teeth diagnosed with irreversible pulpitis, as it preserves tooth structure, enhances healing potential in the remaining pulp promoting long-term clinical and radiographic success.

Recently, the concept of a newer economical material "3Mixtatin" has come into research and has been studied for its use in direct pulp capping, inflammatory root resorption, and pulpotomy in primary teeth. The material is a combination of 3Mix (cefixime, metronidazole, and ciprofloxacin) and a statin (Simvastatin).

3Mixtatin, incorporates Simvastatin, an antihyperlipidemic drug, into the triple antibiotic paste, Simvastatin was used as an anti inflammatory and bioinductive agent, whereas 3Mix served as an antibacterial agent.

Statin components are emerging materials in regenerative dentistry. Evidence from both experimental and clinical studies supports the notion of 'pleiotropic' effects of statins, they improve osteoblasts function and suppress function of osteoclast leading to enhanced bone formation. Therefore, they might improve odontoblastic function resulting in improved dentin formation. Statins are also thought to induce angiogenesis and increase neuronal cell. Consequently, they play a role in pulp regeneration along with dentin regeneration. In addition, sufficient evidence exists in support of the potent anti-inflammatory properties of statins, they reduce circulating C-reactive protein (CRP) and pro-inflammatory cytokines, lowering the amount of interleukin-6 and interleukin-8 in inflamed pulpal tissues.

Owing to limited availability of data in researches and in order to reach conclusive results on whether pulpotomy can be offered as an alternate treatment to pulpectomy in vital primary molars diagnosed with irreversible pulpitis, our study aims to evaluate clinical and radiographic success of of pulpotomy using 3Mixtatin versus pulpectomy using Metapex with vital primary molars diagnosed with symptomatic irreversible pulpitis in children aged 4 to 9 years.

Conditions

Irreversible Pulpitis; Primary Teeth; Pulp Disease, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

metapex pulpectomy

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

Group Type: ACTIVE_COMPARATOR

Metapex

Intervention Type: DRUG

Pulpectomy using Metapex

3Mixtatin Pulpotomy

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

Group Type: EXPERIMENTAL

3Mixtatin

Intervention Type: DRUG

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

Interventions

Metapex

Pulpectomy using Metapex

Intervention Type: DRUG

3Mixtatin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

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.
• 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nora Mohamed Mosaad Hussien

Pedodontist, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Osama Ibrahim El Shahawy, Professor

Role: STUDY_DIRECTOR

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

Marwa Aly Fouad, Associate professor

Role: STUDY_CHAIR

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

Central Contacts

Nora Mohamed Mosaad, PHD researcher

Role: CONTACT

nora.mosaad@dentistry.cu.edu.eg

00201000921189

Marwa Aly Fouad, Associate Professor

Role: CONTACT

marwaaly2003@yahoo.com

Other Identifiers

3Mixtatin and Metapex pulpitis

Identifier Type: -

Identifier Source: org_study_id