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Enrolling by Invitation

NCT Number: NCT06926322

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

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.

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Key information

Conditions

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

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry Ain shams university

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

chitosan-coated silver nanoparticles

Drug

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

Primary outcomes

  1. Clinical success

    Time frame: 1,6, and 12 months follow up

    • 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

  2. Radiographic success

    Time frame: 6 and 12 months follow up

    • Absence/decrease/stasis of furcation radiolucency related to the treated teeth
    • Absence/stasis of pathological root resorption of the treated teeth

Secondary outcomes

  1. Antibacterial activity of studied medicaments against Enterococcus Faecalis bacteria

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Apr 13, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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