Clinical trial NCT06925490: Comparison of 3Mixtatin Pulpotomy and Metapex Pulpectomy in Primary Molars With Irreversible Pulpitis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Irreversible Pulpitis
Primary Teeth
Pulp Disease, Dental
Keywords: 3Mixtatin
irreversible pulpitis
metapex
pulpectomy
pulpotomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical success
timeFrame: 3, 6, 9, and 12 months follow-up period
Secondary outcomes:
measure: Radiographic Success
timeFrame: 6 and 12 months
measure: Post operative pain
timeFrame: 1 week, 3, 6, 9, and 12 months.
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
name: Osama Ibrahim El Shahawy, Professor
role: STUDY_DIRECTOR
affiliation: Associate Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
name: Marwa Aly Fouad, Associate professor
role: STUDY_CHAIR
References: