Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional double antibiotic paste of Metronidazole 500 mg plus Ciprofloxacin 500 mg mixed with propylene glycol, Double antibiotic paste of Metronidazole and Ciprofloxacin loaded chitosan-coated silver nanoparticles, chitosan-coated silver nanoparticles.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative, Root Resorption, Persistent Infection, Necrotic Pulp. Basic parameters: 4 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Nano-based Medicaments Versus Double Antibiotic Paste in Managing Non-vital Primary Molars: A Randomized Clinical Trial and In-Vitro Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Clinical success [Time frame: 1,6, and 12 months follow up]
- Radiographic success [Time frame: 6 and 12 months follow up]
Secondary outcome measures (1)
- Antibacterial activity of studied medicaments against Enterococcus Faecalis bacteria [Time frame: 2 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of dentistry Ain shams university — Cairo
Identifiers
NCT: NCT06926322 · PED-25-D1