Early Childhood CariesNCT05255913
Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries
A study testing Nanosilver and Silver diamine fluoride in people with Early Childhood Caries, run by Alexandria University at 1 site in Egypt.
Trial summary
Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after sex and twelve months in arresting ECC lesions. The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children… Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Nanosilver and Silver diamine fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 3 Aug 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 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children younger than 4 years old.
- The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
- Completion of an informed consent to participate in the study.
Who cannot join
- Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility.
- Parental refusal to participate in the study.
- Allergy or sensitivity to silver or any of the materials included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries (a Randomized Clinical Trial)
Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after sex and twelve months in arresting ECC lesions.
The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ECC.
- Conditions
- Early Childhood Caries
- Being tested
- Nanosilver, Silver diamine fluoride
- Keywords
- Caries arrest, early childhood caries, Nanosilver fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanosilverDrug
preventive material for arresting caries
Silver diamine fluorideDrug
preventive material for arresting caries
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Not described Receives: Drug: Nanosilver |
| group 2 | Active comparator | Not described Receives: Drug: Silver diamine fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries arrest
percentage of arresting caries in primary teeth
Measured: 6 months and 1 year
Secondary outcomes (3)
Comparing parental satisfaction and adverse effects with interventions
assessed by a self-rated questionnaire with responses on a 4-point Likert scale ranging from very satisfied, satisfied, unsatisfied, to very unsatisfied - Parents were also asked about adverse effects
Measured: 6 months
Evaluating oral health related quality of life of children and their families.
by using the Arabic version of the Early Childhood Oral Health Impact Scale (A-ECOHIS)
Measured: 6 months and 1 year
Assessing caries increment on remaining teeth in the oral cavity other than the tooth/ teeth receiving the preventive agent
caries increment which is the number of new caries lesions developed over the study period detected using dmfs (change in dmfs score)
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start15 Mar 2022
- Primary completion25 Jul 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Quritum, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255913
- Sponsor's protocol ID
- 0265-07/2021
- Status last verified
- Sep 2023
- First submitted
- 16 Feb 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Quritum M, Abdella A, Amer H, El Desouky LM, El Tantawi M. Effectiveness of nanosilver fluoride and silver diamine fluoride in arresting early childhood caries: a randomized controlled clinical trial. BMC Oral Health. 2024 Jun 18;24(1):701. doi: 10.1186/s12903-024-04406-3.
PubMed 38890627Quritum M, Abdella A, Amer H, El Tantawi M. Effect of silver diamine fluoride and nano silver fluoride on oral health-related quality of life of children with early childhood caries: A randomized clinical trial. J Dent. 2024 Mar;142:104878. doi: 10.1016/j.jdent.2024.104878. Epub 2024 Feb 2.
PubMed 38311016
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries (a Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05255913
- Acronym / sponsor ID
- 0265-07/2021
- Conditions
- Early Childhood Caries
- Keywords
- Caries arrest, early childhood caries, Nanosilver fluoride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 25 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.
Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after sex and twelve months in arresting ECC lesions.
The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ECC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Nanosilver |
| group 2 | Active comparator | Drug: Silver diamine fluoride |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children younger than 4 years old.
- The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
- Completion of an informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility.
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 |
|---|---|---|
| Nanosilverpreventive material for arresting caries | Drug | group 1 |
| Silver diamine fluoridepreventive material for arresting caries | Drug | group 2 |
Primary outcome
caries arrest
Time frame: 6 months and 1 year
percentage of arresting caries in primary teeth
3 secondary outcomes
Comparing parental satisfaction and adverse effects with interventions
Time frame: 6 months
Evaluating oral health related quality of life of children and their families.
Time frame: 6 months and 1 year
Assessing caries increment on remaining teeth in the oral cavity other than the tooth/ teeth receiving the preventive agent
Time frame: 6 months and 1 year
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 26 Sep 2023.
- Derived from this study: PubMed 38890627Quritum M, Abdella A, Amer H, El Desouky LM, El Tantawi M. Effectiveness of nanosilver fluoride and silver diamine fluoride in arresting early childhood caries: a randomized controlled clinical trial. BMC Oral Health. 2024 Jun 18;24(1):701. doi: 10.1186/s12903-024-04406-3.
- Derived from this study: PubMed 38311016Quritum M, Abdella A, Amer H, El Tantawi M. Effect of silver diamine fluoride and nano silver fluoride on oral health-related quality of life of children with early childhood caries: A randomized clinical trial. J Dent. 2024 Mar;142:104878. doi: 10.1016/j.jdent.2024.104878. Epub 2024 Feb 2.
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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 Nanosilver and Silver diamine fluoride in people with Early Childhood Caries, run by Alexandria 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: finished, as of the sponsor's last update on 26 Sep 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?
caries arrest (time frame: 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05255913, which also lists 2 linked publications.
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 26 Sep 2023.