Clinical trial NCT06926322: Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
Official title: Nano-based Medicaments Versus Double Antibiotic Paste in Managing Non-vital Primary Molars: A Randomized Clinical Trial and In-Vitro Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Root Resorption
Persistent Infection
Necrotic Pulp
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 108
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical success
timeFrame: 1,6, and 12 months follow up
measure: Radiographic success
timeFrame: 6 and 12 months follow up
Secondary outcomes:
measure: Antibacterial activity of studied medicaments against Enterococcus Faecalis bacteria
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Nagwa Khattab
role: STUDY_DIRECTOR
References: