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

Ain Shams University

Status: Invitation-only

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

Treatments: Drug: chitosan-coated silver nanoparticles; Drug: Conventional double antibiotic paste of Metronidazole 500 mg plus Ciprofloxacin 500 mg mixed with propylene glycol; Drug: Double antibiotic paste of Metronidazole and Ciprofloxacin loaded chitosan-coated silver nanoparticles

Study type: Interventional

Funder types: Other

Identifiers

NCT06926322

PED-25-D1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups

Conventional double antibiotic paste

Active Comparator group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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

chitosan-coated silver nanoparticles

Experimental group

Description:

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.

Treatment:

Drug: chitosan-coated silver nanoparticles