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3Mixtatin Versus Modified 3Mix-MP in Lesion Sterilization and Tissue Repair for Treatment of Necrotic Primary Molars

NCT05677945 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-01-10

No results posted yet for this study

Summary

This randomized clinical study aims to assess the clinical and radiographic success rate of the 3Mixtatin versus the 3Mix in LSTR in necrotic primary molars.

Conditions

  • Necrotic Primary Molars

Interventions

DRUG

3Mixtatin paste: Simvastatin mixed with modified triple antibiotic

* Drying the mucosa with gauze,topical anesthesia will be applied. * Administration of local anesthesia with vasoconstrictor. * Rubber dam isolation. * Caries removal \& access cavity using a round bur mounted on a high-speed contra with coolant. * Removal of necrotic pulp tissue in coronal portion of the tooth using sharp excavator. * Radicular section will be kept untouched,no instrumentation. * Using disposable syringe Irrigation of the pulp chamber with 2.5% NaOCl. * In case of hemorrhage moist cotton immersed in 1% NaOCL will be placed to achieve hemostasis. * Drying the access cavity with sterile cotton pellets. * Freshly mixed 3Mix-MP or 3Mixtatin paste (according to group of intervention) will be transferred to the floor of the pulp chamber using an amalgam carrier \& condensed over orifices using a moist cotton pellet. * Cavity sealing with RMGI capsules. * Same visit placement with preformed Stainless-steel crown(3M® ESPE)cemented with glass ionomer cement.

DRUG

3Mix: Modified triple antibiotic mix in propylene glycol

* Drying the mucosa with gauze,topical anesthesia will be applied. * Administration of local anesthesia with vasoconstrictor. * Rubber dam isolation. * Caries removal \& access cavity using a round bur mounted on a high-speed contra with coolant. * Removal of necrotic pulp tissue in coronal portion of the tooth using sharp excavator. * Radicular section will be kept untouched,no instrumentation. * Using disposable syringe Irrigation of the pulp chamber with 2.5% NaOCl. * In case of hemorrhage moist cotton immersed in 1% NaOCL will be placed to achieve hemostasis. * Drying the access cavity with sterile cotton pellets. * Freshly mixed 3Mix-MP or 3Mixtatin paste (according to group of intervention) will be transferred to the floor of the pulp chamber using an amalgam carrier \& condensed over orifices using a moist cotton pellet. * Cavity sealing with RMGI capsules. * Same visit placement with preformed Stainless-steel crown(3M® ESPE)cemented with glass ionomer cement.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Rania Nasr, Professor · Professor of pediatric dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2024-03-31
Completion
2024-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05677945 on ClinicalTrials.gov