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.
Trial 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… Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
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.
- 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 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
- Absence/decrease of pain related to the treated teeth including patient reported pain or sensitivity to palpation/percussion
- Absence/decrease of gingival swelling related to the treated teeth
- Absence/decrease of pathological mobility related to the treated teeth
Measured: 1,6, and 12 months follow up
Radiographic success
- Absence/decrease/stasis of furcation radiolucency related to the treated teeth
- 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.
- 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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ehab Abdel Razik Kamel, Ain Shams University
- Investigators
- Nagwa Khattab, Study director, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nano-based Medicaments Versus Double Antibiotic Paste in Managing Non-vital Primary Molars: A Randomized Clinical Trial and In-Vitro Study
- ClinicalTrials.gov ID
- NCT06926322
- Acronym / sponsor ID
- PED-25-D1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional double antibiotic paste | Active comparator | Drug: Conventional double antibiotic paste of Metronidazole 500 mg plus Ciprofloxacin 500 mg mixed with propylene glycolAfter 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. |
| double antibiotic paste-loaded chitosan-coated silver nanoparticles | Experimental | Drug: Double antibiotic paste of Metronidazole and Ciprofloxacin loaded chitosan-coated silver nanoparticlesAfter 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. |
| chitosan-coated silver nanoparticles | Experimental | Drug: chitosan-coated silver nanoparticlesAfter 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. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional double antibiotic paste of Metronidazole 500 mg plus Ciprofloxacin 500 mg mixed with propylene glycolThe studied medicament will be placed onto the floor of the pulp chamber. | Drug | Conventional double antibiotic paste |
| Double antibiotic paste of Metronidazole and Ciprofloxacin loaded chitosan-coated silver nanoparticlesThe studied medicament will be placed onto the floor of the pulp chamber. | Drug | double antibiotic paste-loaded chitosan-coated silver nanoparticles |
| chitosan-coated silver nanoparticlesThe studied medicament will be placed onto the floor of the pulp chamber. | Drug | chitosan-coated silver nanoparticles |
Primary outcome
Clinical success
Time frame: 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
Time frame: 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
1 secondary outcome
Antibacterial activity of studied medicaments against Enterococcus Faecalis bacteria
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nagwa Khattab study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 1,6, and 12 months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.