Early Childhood CariesPhase 3NCT05761041
Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries
A Phase 3 study testing Sodium Fluoride Varnish (5%), Motivational Interviewing and SDF in people with Early Childhood Caries, run by Alexandria University at 1 site in Egypt.
Trial summary
Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for the management of early childhood caries (ECC). However, black staining is one of its drawbacks. Read more about this study
- Who is it for?
- Ages 1 year to 4 years
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Sodium Fluoride Varnish (5%), Motivational Interviewing and SDF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2022to 15 Apr 2023
- Phase
- Phase 3
- 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 1 year to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged ≤ 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)
- Children whose caregivers have means of communication (mobile phones).
- 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.
- 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 Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial
Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for the management of early childhood caries (ECC). However, black staining is one of its drawbacks. A possible affordable alternative can be Sodium Fluoride (NaF) supported with good oral hygiene induced by parental Motivational Interviewing (MI).
The trial aims to compare the impact of SDF versus NaF supported by MI on lesion activity in preschool children.
- Conditions
- Early Childhood Caries
- Being tested
- Sodium Fluoride Varnish (5%), Motivational Interviewing, SDF
- Keywords
- ECC, 38% SDF, 5% NaF, Motivational Interviewing, Preschoolers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Fluoride Varnish (5%)Drug
Applied at baseline
Motivational InterviewingBehavioural
Two MI sessions: face-to-face at baseline and phone call at 3 months
SDFDrug
Applied bianually
| Study group | Role | What they receive |
|---|---|---|
| Naf + MI | Experimental | Sodium Fluoride Varnish 5% (Applied biannually) + two MI sessions: baseline face-to-face session and phone call after 3months. Receives: Drug: Sodium Fluoride Varnish (5%); Behavioral: Motivational Interviewing |
| SDF | Active comparator | Silver Diamine fluoride 38% (Applied biannually) Receives: Drug: SDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries Arrest
Percentage of arrested carious lesions
Measured: 6 months
Secondary outcomes (2)
Caries Increment
Number of new carious lesions will be assessed using decayed, missing (due to caries), and filled primary tooth surface index (dmfs)
Measured: 6 months
Parental satisfaction
Parents will be asked if application was an easy process, pain free for their child and taste is acceptable. Answers will be on a 5 point Likert scale (Strongly agree, Agree, Neutral , Disagree, Strongly disagree).
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start28 Mar 2022
- Primary completion30 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Science,Technology & Innovation Funding Authority, Egypt
- Responsible party
- Principal investigator, randa hassan abdelsamea yassin, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761041
- Sponsor's protocol ID
- 0272 - 07 /2021
- Status last verified
- Jul 2023
- First submitted
- 14 Feb 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yassin R, Amer H, Tantawi ME. Effectiveness of silver diamine fluoride versus sodium fluoride varnish combined with mother's motivational interviewing for arresting early childhood caries: a randomized clinical trial. BMC Oral Health. 2023 Oct 4;23(1):710. doi: 10.1186/s12903-023-03456-3.
PubMed 37789300
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05761041
- Acronym / sponsor ID
- 0272 - 07 /2021
- Conditions
- Early Childhood Caries
- Keywords
- ECC, 38% SDF, 5% NaF, Motivational Interviewing, Preschoolers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Science,Technology & Innovation Funding Authority, Egypt
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 9 Mar 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.
Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for the management of early childhood caries (ECC). However, black staining is one of its drawbacks. A possible affordable alternative can be Sodium Fluoride (NaF) supported with good oral hygiene induced by parental Motivational Interviewing (MI).
The trial aims to compare the impact of SDF versus NaF supported by MI on lesion activity in preschool children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naf + MI | Experimental | Drug: Sodium Fluoride Varnish (5%), Behavioral: Motivational InterviewingSodium Fluoride Varnish 5% (Applied biannually) + two MI sessions: baseline face-to-face session and phone call after 3months. |
| SDF | Active comparator | Drug: SDFSilver Diamine fluoride 38% (Applied biannually) |
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged ≤ 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)
- Children whose caregivers have means of communication (mobile phones).
- 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.
- Parental refusal to participate in the study.
- Allergy or sensitivity to silver or any of the materials included in the study.
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 |
|---|---|---|
| Sodium Fluoride Varnish (5%)Applied at baseline | Drug | Naf + MI |
| Motivational InterviewingTwo MI sessions: face-to-face at baseline and phone call at 3 months | Behavioural | Naf + MI |
| SDFApplied bianually | Drug | SDF |
Primary outcome
Caries Arrest
Time frame: 6 months
Percentage of arrested carious lesions
2 secondary outcomes
Caries Increment
Time frame: 6 months
Parental satisfaction
Time frame: Baseline and 6 months
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 20 Jul 2023.
- Derived from this study: PubMed 37789300Yassin R, Amer H, Tantawi ME. Effectiveness of silver diamine fluoride versus sodium fluoride varnish combined with mother's motivational interviewing for arresting early childhood caries: a randomized clinical trial. BMC Oral Health. 2023 Oct 4;23(1):710. doi: 10.1186/s12903-023-03456-3.
- 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 Phase 3 study testing Sodium Fluoride Varnish (5%), Motivational Interviewing and SDF 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 4 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 20 Jul 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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). 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 NCT05761041, which also lists 1 linked publication.
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 20 Jul 2023.