Endodontic DiseaseNCT06172023
Evaluation of Antimicrobial Efficacy and Postoperative Pain After Using Silver Nanoparticles and Chitosan Nanoparticles Against Enterococcus Faecalis and Candida Albicans Biofilm
A study testing Silver Nanoparticles Irrigant and Chitosan Nanoparticles Irrigant in people with Endodontic Disease, run by Minia University at 1 site in Egypt.
Trial summary
Silver nanoparticles possess unique physicochemical and biological properties in addition to their antibacterial capabilities. Similarly, zinc oxide nanoparticles have demonstrated antibacterial effects against a wide range of bacteria, including heat and pressure resistant spores. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease
- What is being tested?
- Silver Nanoparticles Irrigant and Chitosan Nanoparticles Irrigant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically stable healthy patients (category: American society of anesthesiologists class I).
- The patient ranges in age from 20 to 40.
- No sexual orientation
- Necrotic pulp evaluated by thermal or electrical pulp testing.
- Enough crown structure to provide adequate isolation.
- One root and one canal.
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- Patients' desire to engage in this research.
- Patients' comprehension of the visual analogue scale (VAS).
- Patients' ability to sign informed consent.
Who cannot join
- Endodontic treatment for the tooth previously.
- Teeth with poor conditions for using rubber dams.
- Vital pulp tissue was observed throughout the treatment.
- Patients who have a medical condition.
- Teeth with open apices that are immature
- Women who are pregnant or breastfeeding.
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- Psychologically disturbed patients.
- Patients having a history of allergy to any of the research drugs were barred from participation.
- A periodontally affected tooth with grade 2 or 3 mobility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Antimicrobial Efficacy and Postoperative Pain After Using Silver Nanoparticles and Chitosan Nanoparticles Against Enterococcus Faecalis and Candida Albicans Biofilm (An in Vitro - in Vivo Study)
Silver nanoparticles possess unique physicochemical and biological properties in addition to their antibacterial capabilities. Similarly, zinc oxide nanoparticles have demonstrated antibacterial effects against a wide range of bacteria, including heat and pressure resistant spores. Given these characteristics, it would be valuable to evaluate and compare a new irrigation solution containing nanosilver and nanozinc-oxide particles with sodium hypochlorite. Furthermore, Chitosan Nanoparticles are expected to exhibit enhanced antibacterial activity compared to regular-sized Chitosan due to their ability to penetrate and disrupt microbial cell membranes. Consequently, the current study aims to assess and compare the antibacterial activity of Silver Nanoparticles and Chitosan Nanoparticles, as well as their impact on post-operative pain.
- Conditions
- Endodontic Disease
- Being tested
- Silver Nanoparticles Irrigant, Chitosan Nanoparticles Irrigant
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Nanoparticles IrrigantDrug
Nanosilver irrigant solution
Chitosan Nanoparticles IrrigantDrug
Chitosan nanoparticles irrigant solution
| Study group | Role | What they receive |
|---|---|---|
| Silver Nanoparticles Irrigant | Experimental | Not described Receives: Drug: Silver Nanoparticles Irrigant |
| Chitosan Nanoparticle Irrigant | Experimental | Not described Receives: Drug: Chitosan Nanoparticles Irrigant |
| 2.6% NaOCl and 17% EDTA sol | Active comparator | Not described Receives: Drug: Silver Nanoparticles Irrigant; Drug: Chitosan Nanoparticles Irrigant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Assessment
Each patient was given a pain scale chart (VAS scale) before every endodontic operation to record his or her pain level. The VAS is a 10-point scale with values ranging from 0 to 10, with 0 representing "No pain," (1-3) representing "mild pain," (4-6) representing "moderate pain," and (7-10) representing "worst imaginable pain." At 6, 12, 24, 48, and 72 hours, each patient was instructed to use the VAS scale (0-10) to rate the presence and severity of discomfort after obturation.
Measured: 6, 12, 24, 48, and 72 hours
Secondary outcomes (1)
Antimicrobial Activity Assessment
A sterile paper point was placed in each root canal to a level roughly 1 mm short of the apex, depending on working length radiographs, to get a sample from the root canal. The samples were suspended in a suspension of 25 microliters, which was pipetted onto a BHI agar plate. The colonies were counted using a Reichert-Jung colony counter after 1 hour, 24 hours, 7 days, and 30 days of incubation at 37oC in an anaerobic jar.
Measured: 1 hour, 24 hours, 7 days, and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jan 2020
- Primary completion1 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- More trials run by Minia 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Amr El Wakad, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172023
- Sponsor's protocol ID
- (RHDIRB2017122004) (438)
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 15 Dec 2023
- 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antimicrobial Efficacy and Postoperative Pain After Using Silver Nanoparticles and Chitosan Nanoparticles Against Enterococcus Faecalis and Candida Albicans Biofilm (An in Vitro - in Vivo Study)
- ClinicalTrials.gov ID
- NCT06172023
- Acronym / sponsor ID
- (RHDIRB2017122004) (438)
- Conditions
- Endodontic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 15 Dec 2023 (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.
Silver nanoparticles possess unique physicochemical and biological properties in addition to their antibacterial capabilities. Similarly, zinc oxide nanoparticles have demonstrated antibacterial effects against a wide range of bacteria, including heat and pressure resistant spores. Given these characteristics, it would be valuable to evaluate and compare a new irrigation solution containing nanosilver and nanozinc-oxide particles with sodium hypochlorite. Furthermore, Chitosan Nanoparticles are expected to exhibit enhanced antibacterial activity compared to regular-sized Chitosan due to their ability to penetrate and disrupt microbial cell membranes. Consequently, the current study aims to assess and compare the antibacterial activity of Silver Nanoparticles and Chitosan Nanoparticles, as well as their impact on post-operative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Silver Nanoparticles Irrigant | Experimental | Drug: Silver Nanoparticles Irrigant |
| Chitosan Nanoparticle Irrigant | Experimental | Drug: Chitosan Nanoparticles Irrigant |
| 2.6% NaOCl and 17% EDTA sol | Active comparator | Drug: Silver Nanoparticles Irrigant, Drug: Chitosan Nanoparticles Irrigant |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Medically stable healthy patients (category: American society of anesthesiologists class I).
- The patient ranges in age from 20 to 40.
- No sexual orientation
- Necrotic pulp evaluated by thermal or electrical pulp testing.
- Enough crown structure to provide adequate isolation.
Key exclusion criteria (9 listed)
- Endodontic treatment for the tooth previously.
- Teeth with poor conditions for using rubber dams.
- Vital pulp tissue was observed throughout the treatment.
- Patients who have a medical condition.
- Teeth with open apices that are immature
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 |
|---|---|---|
| Silver Nanoparticles IrrigantNanosilver irrigant solution | Drug | 2.6% NaOCl and 17% EDTA sol, Silver Nanoparticles Irrigant |
| Chitosan Nanoparticles IrrigantChitosan nanoparticles irrigant solution | Drug | 2.6% NaOCl and 17% EDTA sol, Chitosan Nanoparticle Irrigant |
Primary outcome
Postoperative Pain Assessment
Time frame: 6, 12, 24, 48, and 72 hours
Each patient was given a pain scale chart (VAS scale) before every endodontic operation to record his or her pain level. The VAS is a 10-point scale with values ranging from 0 to 10, with 0 representing "No pain," (1-3) representing "mild pain," (4-6) representing "moderate pain," and (7-10) representing "worst imaginable pain." At 6, 12, 24, 48, and 72 hours, each patient was instructed to use the VAS scale (0-10) to rate the presence and severity of discomfort after obturation.
1 secondary outcome
Antimicrobial Activity Assessment
Time frame: 1 hour, 24 hours, 7 days, and 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Endodontic Disease
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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Nanoparticles Irrigant and Chitosan Nanoparticles Irrigant in people with Endodontic Disease, run by Minia 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 15 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Pain Assessment (time frame: 6, 12, 24, 48, and 72 hours). 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 15 Dec 2023.