Caries,DentalNCT05231330
Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions
A study testing silvernanoparticles and SDF in people with Caries,Dental, run by Suez Canal University at 1 site in Egypt.
Trial summary
this clinical study will be carried out to evaluate the effect of fluoride varnish with silver nanoparticles in comparison to silver diamine fluoride in management of deep carious lesions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- silvernanoparticles and SDF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Mar 2021
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- success will be evaluated by:
- Cold pulp testing: An ice-rod will be used for this test. Results should be positive or negative.
- Absence of spontaneous pain: Post-operative pain will be assessed using the visual Analogue Scale Score (VAS), which is a measurement method for subjective characteristics of pain. Respondents specify their level of agreement to a statement by indicating a position along a 10 cm line between two end-points, with the term "no sensitivity" at one end and "intolerable sensitivity" at the other end. A score from (0 to 10 is given).
- Sensitivity to percussion: (presence/ absence).
- Inspection for Sinus/fistula/swelling: using visual inspection (presence/ absence).
- Radiographic examination: Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence).
Who cannot join
- Patient-related criteria:
- Medically compromised patients, who will not be able to attend multiple appointments or may require special management.
- Pregnant women; as radiographs cannot be taken for them.
- Allergy to any of the restorative materials, including anesthetics.
- Uncooperative patients, will not abide by the instructions or attend the appointments.
- Tooth related criteria:
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- Retained deciduous teeth; as the study is targeting only permanent teeth.
- Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries.
- Teeth with cervical caries; which can't be evaluated on periapical radiographs
Trial locations and contacts
1 site in 1 country.
About this study
this clinical study will be carried out to evaluate the effect of fluoride varnish with silver nanoparticles in comparison to silver diamine fluoride in management of deep carious lesions.
- Conditions
- Caries,Dental
- Being tested
- silvernanoparticles, SDF
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silvernanoparticlesDrug
silvernanoparticles in fluoride varnish
SDFDrug
Also called silver diamine fluoride
silver diamine fluoride
| Study group | Role | What they receive |
|---|---|---|
| silver nanoparticles | Experimental | Not described Receives: Drug: silvernanoparticles |
| silverdiamine fluoride | Active comparator | Not described Receives: Drug: SDF |
| no medicament | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold pulp testing
: An ice-rod will be used for this test. Results should be positive or negative.
Measured: 6 months
Absence of spontaneous pain
Post-operative pain will be assessed using the visual Analogue Scale Score (VAS), which is a measurement method for subjective characteristics of pain. Respondents specify their level of agreement to a statement by indicating a position along a 10 cm line between two end-points, with the term "no sensitivity" at one end and "intolerable sensitivity" at the other end. A score from (0 to 10 is given).
Measured: 6 month
Radiographic examination
Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence).
Measured: 6 month
sensitivity to percussion
recorded as yes or no
Measured: 6 month
visual inspection for sinus/ fistula swelling
recorded as yes or no
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Mar 2020
- Primary completion1 Oct 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Hamdy Ahmed Aly, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231330
- Sponsor's protocol ID
- HR1
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions
- ClinicalTrials.gov ID
- NCT05231330
- Acronym / sponsor ID
- HR1
- Conditions
- Caries,Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 9 Feb 2022 (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.
this clinical study will be carried out to evaluate the effect of fluoride varnish with silver nanoparticles in comparison to silver diamine fluoride in management of deep carious lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| silver nanoparticles | Experimental | Drug: silvernanoparticles |
| silverdiamine fluoride | Active comparator | Drug: SDF |
| no medicament | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- success will be evaluated by:
Key exclusion criteria (9 listed)
- Patient-related criteria:
- Retained deciduous teeth; as the study is targeting only permanent teeth.
- Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries.
- Teeth with cervical caries; which can't be evaluated on periapical radiographs
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 |
|---|---|---|
| silvernanoparticlessilvernanoparticles in fluoride varnish | Drug | silver nanoparticles |
| SDFAlso: silver diamine fluoridesilver diamine fluoride | Drug | silverdiamine fluoride |
Primary outcome
Cold pulp testing
Time frame: 6 months
: An ice-rod will be used for this test. Results should be positive or negative.
Absence of spontaneous pain
Time frame: 6 month
Post-operative pain will be assessed using the visual Analogue Scale Score (VAS), which is a measurement method for subjective characteristics of pain. Respondents specify their level of agreement to a statement by indicating a position along a 10 cm line between two end-points, with the term "no sensitivity" at one end and "intolerable sensitivity" at the other end. A score from (0 to 10 is given).
Radiographic examination
Time frame: 6 month
Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence).
sensitivity to percussion
Time frame: 6 month
recorded as yes or no
visual inspection for sinus/ fistula swelling
Time frame: 6 month
recorded as yes or no
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 9 Feb 2022.
- Individual participant dataSharing planned: No
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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. 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 silvernanoparticles and SDF in people with Caries,Dental, run by Suez Canal 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 6 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 9 Feb 2022. 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?
Cold pulp testing (time frame: 6 months). The study lists 5 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 9 Feb 2022.