3Mixtatin and MTA Vital Pulpotomy in Primary Molars

Phase 1Not Yet RecruitingNCT06478940

Cairo University50 enrolled

Overview

The aim of the study is to evaluate clinical and radiographic success of using 3Mixtain versus mineral trioxide aggregate in pulpotomy of deeply carious Primary molars.

Due to the complexity of the root canal microbiome, it is doubtful that they can be treated properly with a single antibiotic. Accordingly, a combination of multiple antibiotics seemed to be essential to diminish different types of pathogenic bacteria. Recently, a combination of three antibiotics (Metronidazole, cefixime, and Ciprofloxacin) along with Statins (new bio-inductive materials in regenerative dentistry) has shown promising results in primary teeth pulp therapy. Statin components have an anti-inflammatory impact on pulp tissue by lowering the amount of interleukin-6 and interleukin-8. They also decrease osteoclastic processes and strengthen osteoblastic processes. Thus, they promote bone regeneration and dentin formation by enhancing odontoblastic activity. Several studies have shown a clinical and radiographic success rate of 3Mixtatin with inconsistent results. Some randomized controlled Trials (RCTs) showed that MTA had a comparable result with 3Mixtatin, while others reported that 3Mixtatin might be an alternative for MTA due to its higher overall success rate. 3Mixtatin is considered as a novel material with successful outcomes. Owing to limited availability of data in researches and in order to reach a conclusive results our study aims to evaluate clinical and radiographic success of using 3Mixtain versus mineral trioxide aggregate in pulpotomy of deeply carious Primary molars .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pulp Disease, Dental Deciduous Teeth

Interventions

3 mixtatin pulpotomyDRUG

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

MTA pulpotomyDRUG

pulp treatment with applying MTA

Eligibility

Sex: ALLMin age: 4 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * • Children 4-8 years old * Vital deeply carious primary molars. * No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule. * Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test. * Patient and parent showing cooperation and compliance. Exclusion Criteria: * • Uncooperative children to avoid time waste and attrition bias. * Unrestorable molars * Sign of radiolucency in periapical or furcation area * Widening of PDL space or loss of lamina dura continuity * Evidence of internal/external pathologic root resorption * During operative procedure, when hemorrhage control is not achievable after pulpotomy. * Children with systemic disease as some systemic diseases may have effect on the outcome. * Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases. * Refusal of participation as the parent of child has the authority of participation.

Outcomes

Primary Outcomes

Clinical success Clinical success clinical success

absence of postoperative pain,Absence of pain on percussion,Absence of Swelling and Absence of Sinus or fistula

Time frame: 1 week , 3 months , 6 months , 9 months and 12 months

Secondary Outcomes

Radiographic success radiographic success

Absence of any adverse radiographic findings (Periodontal membrane space widening, bone resorption, pulp stones, internal or external root resorption )

Time frame: 3 months , 6 months , 12 months

Central Contacts

Sally A kotb, PHD researcher

CONTACT

00201001656502 sallyqutb9933@gmail.com

Eslam M Mahdy

CONTACT

00201143683135 eslam.mahdy@dentistry.cu.edu.eg

Data from ClinicalTrials.gov

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