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

NCT06926322 | Enrolling By Invitation DMC

• 1 other identifier: PED-25-D1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Clinical success

  1. Absence/decrease of pain related to the treated teeth including patient reported pain or sensitivity to palpation/percussion 2. Absence/decrease of gingival swelling related to the treated teeth 3. Absence/decrease of pathological mobility related to the treated teeth

  1,6, and 12 months follow up

• Radiographic success

  1. Absence/decrease/stasis of furcation radiolucency related to the treated teeth 2. Absence/stasis of pathological root resorption of the treated teeth

  6 and 12 months follow up

Secondary Outcomes (1)

• Antibacterial activity of studied medicaments against Enterococcus Faecalis bacteria

  2 weeks

Study Arms (3)

Conventional double antibiotic paste

ACTIVE COMPARATOR

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

double antibiotic paste-loaded chitosan-coated silver nanoparticles

EXPERIMENTAL

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

chitosan-coated silver nanoparticles

EXPERIMENTAL

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

Interventions

Conventional double antibiotic paste of Metronidazole 500 mg plus Ciprofloxacin 500 mg mixed with propylene glycol DRUG

The studied medicament will be placed onto the floor of the pulp chamber.

Conventional double antibiotic paste

Double antibiotic paste of Metronidazole and Ciprofloxacin loaded chitosan-coated silver nanoparticles DRUG

The studied medicament will be placed onto the floor of the pulp chamber.

double antibiotic paste-loaded chitosan-coated silver nanoparticles

chitosan-coated silver nanoparticles DRUG

The studied medicament will be placed onto the floor of the pulp chamber.

chitosan-coated silver nanoparticles

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of dentistry Ain shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Root Resorption; Persistent Infection; Dental Pulp Necrosis

Interventions

Ciprofloxacin; Propylene Glycol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Tooth Resorption; Tooth Diseases; Stomatognathic Diseases; Infections; Disease Attributes; Dental Pulp Diseases; Necrosis

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Officials

• Nagwa Khattab

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The current study will be a triple-blind study. The participants will be blind to the study groups they will be assigned to. The evaluators will also be blind to the study groups during clinical and radiographic examination. The operator will not be blind to the study groups because of the difference between the used medicaments. The statistician will be unaware of the study group's allocation during statistical analysis of the data collected.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Pediatric Dentistry

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: April 13, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2030
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

EG (1)