NCT06926322

Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair

Nano-based Medicaments Versus Double Antibiotic Paste in Managing Non-vital Primary Molars: A Randomized Clinical Trial and In-Vitro Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

Summary

Management of non-vital primary molars is challenging due to the natural anatomy of primary teeth, patients' young age, and their behavior toward dental treatment. A simple and effective technique such as Lesion Sterilization and Tissue Repair offers a solution to cases with poor prognosis; however, the medicaments used in this technique have some limitations. This study will evaluate three different medicaments regarding the clinical success, radiographic success, and antibacterial activity.

Detailed description

This randomized controlled trial will include 108 non-vital mandibular primary molars in children aged 4-8. Patients will be randomly allocated into three groups according to the studied medicaments as one positive control group and two experimental groups. The groups are as follows: Group I (conventional double antibiotic paste) positive control group Group II (double antibiotic paste-loaded chitosan-coated silver nanoparticles) experimental group Group III (chitosan-coated silver nanoparticles) experimental group The antibacterial activity of studied medicaments will be tested against Enterococcus Faecalis bacteria in planktonic and biofilm forms. Teeth will be evaluated clinically and radiographically to obtain baseline data. After local anesthesia administration and isolation of teeth, an access cavity will be performed, then the medicament will be placed over the floor of the pulp chamber according to the corresponding group. Afterwards, teeth will be filled with resin-modified zinc oxide and eugenol followed by stainless steel crowns. Blinded clinical evaluation will be done at baseline, 1, 6, and 12 months and blinded radiographic evaluation will be done at baseline, 6, and 12 months.

Conditions

• Pain, Postoperative
• Root Resorption
• Persistent Infection
• Necrotic Pulp

Interventions

Type	Name	Description
DRUG	Conventional double antibiotic paste of Metronidazole 500 mg plus Ciprofloxacin 500 mg mixed with propylene glycol	The studied medicament will be placed onto the floor of the pulp chamber.
DRUG	Double antibiotic paste of Metronidazole and Ciprofloxacin loaded chitosan-coated silver nanoparticles	The studied medicament will be placed onto the floor of the pulp chamber.
DRUG	chitosan-coated silver nanoparticles	The studied medicament will be placed onto the floor of the pulp chamber.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-08-01
• Completion: 2030-08-01
• First posted: 2025-04-13
• Last updated: 2025-10-02

Locations

1 site across 1 country: Egypt