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

Clinical and Radiographic Evaluation of Pulpotomy Using 3Mixtatin Versus Pulpectomy Using Metapex in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis in Children Aged 4 to 9 Years: A Randomized Clinical Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Pulpitis; Pulp Disease, Dental; Primary Teeth
• Intervention / Treatment: Drug: Metapex; Drug: 3Mixtatin

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nora Mohamed Mosaad, PHD researcher; Phone Number: 00201000921189; Email: nora.mosaad@dentistry.cu.edu.eg
• Study Contact Backup: Name: Marwa Aly Fouad, Associate Professor; Email: marwaaly2003@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: metapex pulpectomy; Single-visit pulpectomy using Metapex, . Calcium hydroxide-iodoform mixture (Metapex) is an ideal pulpal filling material for primary teeth.	Drug: Metapex; Pulpectomy using Metapex
Experimental: 3Mixtatin Pulpotomy; pulpotomy with 3 mixtatin (triple antibiotic paste of (Metronidazole, cefixime, and Ciprofloxacin mixed with simvastatin ) applied in the vital pulp therapy	Drug: 3Mixtatin; pulpotomy treatment when applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Success	Radiolucency at the furcation or periapical area, internal or external root resorption, will be examined (present or not) through digital periapical radiographs.; The radiographic assessments will be performed as baseline data at the first visit following the procedure completion and at 6 and 12 months after the baseline; The Two blind assessors will independently evaluate the radiographic outcomes.	6 and 12 months
Post operative pain	After the completion of treatment, post-operative pain will be assessed using the Visual analog scale. This scale comprises six faces, with numbers ranging from 0 to 10 and word descriptions. During follow-up visits, the patients are asked to point to the face that best represents their feelings.	1 week, 3, 6, 9, and 12 months.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Osama Ibrahim El Shahawy, Professor, professor of pediatric dentistry and dental public health, faculty of dentistry, Cairo University; Study Chair: Marwa Aly Fouad, Associate professor, Associate professor of pediatric dentistry and dental public health, faculty of dentistry, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 6, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pulpotomy; pulpectomy; irreversible pulpitis; 3Mixtatin; metapex
• Additional Relevant MeSH Terms: Tooth Diseases; Pulpitis; Dental Pulp Diseases; Stomatognathic Diseases
• Other Study ID Numbers: 3Mixtatin and Metapex pulpitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No