Pain, PostoperativeNCT06926322

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

A study testing 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 and chitosan-coated silver nanoparticles in people with Pain, Postoperative and Root Resorption, run by Ain Shams University at 1 site in Egypt.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 4 to 8 yearsHealthy volunteers can take part
Conditions the study is for: Pain, Postoperative, Root Resorption, Persistent Infection
What is being tested?: 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 and chitosan-coated silver nanoparticles
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteEgypt
Study dates: 1 Jul 2025to Aug 2030
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site

Faculty of dentistry Ain shams university
Cairo

Other trials in Egypt

About this study

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

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.

Read the 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.

Conditions: Pain, Postoperative, Root Resorption, Persistent Infection, Necrotic Pulp
Being tested: 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
Medical subject headings: Pain, Postoperative, Root Resorption, Persistent Infection, Dental Pulp Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Conventional double antibiotic paste of Metronidazole 500 mg plus Ciprofloxacin 500 mg mixed with propylene glycolDrug
The studied medicament will be placed onto the floor of the pulp chamber.
Double antibiotic paste of Metronidazole and Ciprofloxacin loaded chitosan-coated silver nanoparticlesDrug
The studied medicament will be placed onto the floor of the pulp chamber.
chitosan-coated silver nanoparticlesDrug
The studied medicament will be placed onto the floor of the pulp chamber.

Study groups in NCT06926322
Study group	Role	What they receive
Conventional double antibiotic paste	Active comparator	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. Receives: 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	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. Receives: Drug: Double antibiotic paste of Metronidazole and Ciprofloxacin loaded chitosan-coated silver nanoparticles
chitosan-coated silver nanoparticles	Experimental	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. Receives: Drug: chitosan-coated silver nanoparticles

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical success
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
Measured: 1,6, and 12 months follow up
Radiographic success
1. Absence/decrease/stasis of furcation radiolucency related to the treated teeth
2. Absence/stasis of pathological root resorption of the treated teeth
Measured: 6 and 12 months follow up

Secondary outcomes (1)

Antibacterial activity of studied medicaments against Enterococcus Faecalis bacteria
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 2025Aug 2030

First posted13 Apr 2025
Study start1 Jul 2025
Primary completionAug 2027 (estimated)
Study completionAug 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 108 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06926322
Sponsor's protocol ID: PED-25-D1
Status last verified: Sep 2026
First submitted: 5 Apr 2025
Last updated: 29 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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