Necrotic Pulp, Pain, Postoperative, Persistent Infection, Root Resorption
Conditions
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.
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
DRUGConventional 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.
DRUGDouble antibiotic paste of Metronidazole and Ciprofloxacin loaded chitosan-coated silver nanoparticles
The studied medicament will be placed onto the floor of the pulp chamber.
DRUGchitosan-coated silver nanoparticles
The studied medicament will be placed onto the floor of the pulp chamber.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | 1,6, and 12 months follow up | 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 |
| Radiographic success | 6 and 12 months follow up | 1. Absence/decrease/stasis of furcation radiolucency related to the treated teeth 2. Absence/stasis of pathological root resorption of the treated teeth |
Secondary
| Measure | Time frame |
|---|---|
| Antibacterial activity of studied medicaments against Enterococcus Faecalis bacteria | 2 weeks |
Countries
Egypt
Outcome results
None listed