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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain, Postoperative; Root Resorption; Persistent Infection; Necrotic Pulp
• Intervention / Treatment: Drug: Conventional double antibiotic paste of Metronidazole 500 mg plus Ciprofloxacin 500 mg mixed with propylene glycol; Drug: Double antibiotic paste of Metronidazole and Ciprofloxacin loaded chitosan-coated silver nanoparticles; Drug: chitosan-coated silver nanoparticles

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of dentistry Ain Shams University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Healthy cooperative children of both sexes in the age range of 4-8 years old.
• Children with consenting parents who accept to participate in the study and sign the consent forms.
• Children with mandibular primary molars with clinical and radiographic signs of pulpal necrosis.

Exclusion Criteria:

• Children with hypersensitivity to any of the used medicaments.
• Non-restorable teeth without sufficient coronal structure for placement of rubber dam isolation and restoration with stainless steel crowns
• Non-restorable teeth with perforated pulpal floor

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional double antibiotic paste; After local anesthesia administration and rubber dam isolation, access cavity will be performed and the studied medicament will be placed onto the floor of the pulp chamber. Teeth will be finally restored with stainless steel crowns in the same visit.	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.
Experimental: double antibiotic paste-loaded chitosan-coated silver nanoparticles; After local anesthesia administration and rubber dam isolation, access cavity will be performed and the studied medicament will be placed onto the floor of the pulp chamber. Teeth will be finally restored with stainless steel crowns in the same visit.	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.
Experimental: chitosan-coated silver nanoparticles; After local anesthesia administration and rubber dam isolation, access cavity will be performed and the studied medicament will be placed onto the floor of the pulp chamber. Teeth will be finally restored with stainless steel crowns in the same visit.	Drug: chitosan-coated silver nanoparticles; The studied medicament will be placed onto the floor of the pulp chamber.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success	Absence/decrease of pain related to the treated teeth including patient reported pain or sensitivity to palpation/percussion; Absence/decrease of gingival swelling related to the treated teeth; Absence/decrease of pathological mobility related to the treated teeth	1,6, and 12 months follow up
Radiographic success	Absence/decrease/stasis of furcation radiolucency related to the treated teeth; Absence/stasis of pathological root resorption of the treated teeth	6 and 12 months follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
Antibacterial activity of studied medicaments against Enterococcus Faecalis bacteria	2 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Nagwa Khattab, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: April 5, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Disease Attributes; Dental Pulp Diseases; Tooth Diseases; Infections; Necrosis; Tooth Resorption; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Persistent Infection; Pain, Postoperative; Dental Pulp Necrosis; Root Resorption; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alcohols; Glycols; Propylene Glycols; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Ciprofloxacin; Propylene Glycol
• Other Study ID Numbers: PED-25-D1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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