Early Childhood CariesPhase 3NCT05642494
Silver Diamine Fluoride(SDF) Versus SDF Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries
A Phase 3 study testing SDF and NaF in people with Early Childhood Caries, run by Alexandria University at 1 site in Egypt.
Trial summary
Early childhood caries (ECC) is the most common chronic childhood disease worldwide. Early restorative intervention may treat the disease but this is often difficult especially with uncooperative children so it may be left untreated. 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?
- SDF and NaF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 30 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 ≤ 4 years old.
- The presence of at least one carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II, Appendix 1, Table 1), detected by visual examination.
- The Carious lesion has to be active according to Lesion Activity criteria of coronal caries of ICDAS II.
- Parental consent for children's participation 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.
- Children showing a definite negative behavior (Score 1 Frankel's classification) during clinical examination.
- 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: Comparison of the Effectiveness of Silver Diamine Fluoride Versus Silver Diamine Fluoride Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries: A Randomised Controlled Clinical Trial
Early childhood caries (ECC) is the most common chronic childhood disease worldwide. Early restorative intervention may treat the disease but this is often difficult especially with uncooperative children so it may be left untreated. Remineralization of affected dentin using silver diamine fluoride (SDF) can arrest these lesions.
This trial aims to compare the effectiveness of 38% SDF solution versus 38% SDF solution with 5% sodium fluoride (NaF) varnish after six months in arresting ECC lesions.
- Conditions
- Early Childhood Caries
- Being tested
- SDF, NaF
- Keywords
- ECC, SDF 38%, NaF 5%, preschoolers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDFDevice
Silver Diamine Fluoride 38% (Applied bianually)
NaFDevice
Sodium Fluoride Varnish (5%) (Applied at baseline and after 3 months)
| Study group | Role | What they receive |
|---|---|---|
| SDF+NaF | Experimental | Silver Diamine fluoride 38% (Applied biannually)+ Sodium Fluoride Varnish 5% (Applied every 3 months) Receives: Device: SDF; Device: NaF |
| SDF | Active comparator | Silver Diamine fluoride 38% (Applied biannually) Receives: Device: SDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of arrested carious lesions
For cavitated dentine caries lesions diagnosed as ICDAS code 5 or 6, visual inspection and tactile detection using a 0.5mm ball-ended Community Periodontal Index (CPI) probe without radiograph examination will be used for assessing caries activity according to Lesion Activity criteria of ICDAS II. If a wall or floor of the lesion is soft and easily penetrated by the probe using light force, then it will be diagnosed as active. A lesion with all surfaces being hard and smooth will be diagnosed as arrested caries .For a moderate caries lesion with no visible dentine (ICDAS code 3 or 4) at baseline, it will be classified as arrested caries at follow-up examination if the lesion did not progress to become a cavitated lesion with visible dentine (ICDAS code 5 or 6). Five tooth surfaces (buccal, lingual, mesial, distal and occlusal) will be examined in each posterior tooth and 4 tooth surfaces (labial, lingual, mesial and distal) in each anterior tooth.
Measured: 6 months
Secondary outcomes (10)
Caries Increment (number of new caries lesions)
New caries lesions will be assessed through visual and tactile inspection using the World Health Organization (WHO) criteria for caries diagnosis. Full mouth examination will be conducted with the aid of a WHO CPI probe, and a disposable dental mirror. Five tooth surfaces (buccal, lingual, mesial, distal and occlusal) will be examined in each posterior tooth and 4 tooth surfaces (labial, lingual, mesial and distal) in each anterior tooth to assess the caries increment using the decayed, missing (due to caries), and filled primary tooth index per surface (dmfs).
Measured: 6 months
Parental satisfaction with SDF application
Parents will be asked If SDF Application is an easy process. Answers will be on a 5 point Likert scale (Strongly agree, Agree Neutral , Disagree, Strongly disagree).
Measured: Baseline and at 6 months
Parental satisfaction with SDF application
Parents will be asked if they are comfortable with discoloration of cavities after SDF placement, Answers will be on a 5 point Likert scale (Strongly agree, Agree Neutral , Disagree, Strongly disagree).
Measured: Baseline and at 6 months
Parental satisfaction with SDF application
Parents will be asked If SDF application was pain free for their child .Answers will be on a 5 point Likert scale (Strongly agree, Agree Neutral , Disagree, Strongly disagree).
Measured: Baseline and at 6 months
Parental satisfaction with SDF application
Parents will be asked if The taste of SDF was acceptable to their child.Answers will be on a 5 point Likert scale (Strongly agree, Agree Neutral , Disagree, Strongly disagree).
Measured: Baseline and at 6 months
Adverse effects reported after application of the interventions
Parents will be asked if their child experienced tooth or gum pain after application of the material.
(Yes/No) Question
Measured: Baseline and at 6 months
Adverse effects reported after application of the interventions
The clinician will observe if gum swelling occurred after application of the material.
(Yes/No) Question
Measured: Baseline and at 6 months
Adverse effects reported after application of the interventions
The clinician will observe if gum bleaching occurred after application of the material.
(Yes/No) Question
Measured: Baseline and at 6 months
Adverse effects reported after application of the interventions
Systemic toxicity (nausea, vomiting, generalised discomfort) will be assesses by the clinician at the time of application and by asking the parents one week later.
(Yes/No) Question
Measured: Baseline and at 6 months
Adverse effects reported after application of the interventions
Black staining of each lesion will be clinically observed and recorded (yes/no).
Measured: Baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Mar 2022
- Primary completion30 Mar 2023
- Study completion30 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
- 220 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, Enas Belal, Alexandria University
- Investigators
- Enas B Abdellatif, Bachelor, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642494
- Sponsor's protocol ID
- 0272-07/2021
- Status last verified
- Jul 2023
- First submitted
- 17 Nov 2022
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Abdellatif EB, El Kashlan MK, El Tantawi M. Silver diamine fluoride with sodium fluoride varnish versus silver diamine fluoride in arresting early childhood caries: a 6-months follow up of a randomized field trial. BMC Oral Health. 2023 Nov 17;23(1):875. doi: 10.1186/s12903-023-03597-5.
PubMed 37978488
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Silver Diamine Fluoride Versus Silver Diamine Fluoride Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries: A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05642494
- Acronym / sponsor ID
- 0272-07/2021
- Conditions
- Early Childhood Caries
- Keywords
- ECC, SDF 38%, NaF 5%, preschoolers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Science,Technology & Innovation Funding Authority, Egypt
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 8 Dec 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.
Early childhood caries (ECC) is the most common chronic childhood disease worldwide. Early restorative intervention may treat the disease but this is often difficult especially with uncooperative children so it may be left untreated. Remineralization of affected dentin using silver diamine fluoride (SDF) can arrest these lesions.
This trial aims to compare the effectiveness of 38% SDF solution versus 38% SDF solution with 5% sodium fluoride (NaF) varnish after six months in arresting ECC lesions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDF+NaF | Experimental | Device: SDF, Device: NaFSilver Diamine fluoride 38% (Applied biannually)+ Sodium Fluoride Varnish 5% (Applied every 3 months) |
| SDF | Active comparator | Device: 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 ≤ 4 years old.
- The presence of at least one carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II, Appendix 1, Table 1), detected by visual examination.
- The Carious lesion has to be active according to Lesion Activity criteria of coronal caries of ICDAS II.
- Parental consent for children's participation 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.
- Children showing a definite negative behavior (Score 1 Frankel's classification) during clinical examination.
- 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 |
|---|---|---|
| SDFSilver Diamine Fluoride 38% (Applied bianually) | Device | SDF, SDF+NaF |
| NaFSodium Fluoride Varnish (5%) (Applied at baseline and after 3 months) | Device | SDF+NaF |
Primary outcome
The percentage of arrested carious lesions
Time frame: 6 months
For cavitated dentine caries lesions diagnosed as ICDAS code 5 or 6, visual inspection and tactile detection using a 0.5mm ball-ended Community Periodontal Index (CPI) probe without radiograph examination will be used for assessing caries activity according to Lesion Activity criteria of ICDAS II. If a wall or floor of the lesion is soft and easily penetrated by the probe using light force, then it will be diagnosed as active. A lesion with all surfaces being hard and smooth will be diagnosed as arrested caries .For a moderate caries lesion with no visible dentine (ICDAS code 3 or 4) at baseline, it will be classified as arrested caries at follow-up examination if the lesion did not progress to become a cavitated lesion with visible dentine (ICDAS code 5 or 6). Five tooth surfaces (buccal, lingual, mesial, distal and occlusal) will be examined in each posterior tooth and 4 tooth surfaces (labial, lingual, mesial and distal) in each anterior tooth.
10 secondary outcomes
Caries Increment (number of new caries lesions)
Time frame: 6 months
Parental satisfaction with SDF application
Time frame: Baseline and at 6 months
Parental satisfaction with SDF application
Time frame: Baseline and at 6 months
Parental satisfaction with SDF application
Time frame: Baseline and at 6 months
Parental satisfaction with SDF application
Time frame: Baseline and at 6 months
Adverse effects reported after application of the interventions
Time frame: Baseline and at 6 months
Adverse effects reported after application of the interventions
Time frame: Baseline and at 6 months
Adverse effects reported after application of the interventions
Time frame: Baseline and at 6 months
Adverse effects reported after application of the interventions
Time frame: Baseline and at 6 months
Adverse effects reported after application of the interventions
Time frame: Baseline and at 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 19 Jul 2023.
- Derived from this study: PubMed 37978488Abdellatif EB, El Kashlan MK, El Tantawi M. Silver diamine fluoride with sodium fluoride varnish versus silver diamine fluoride in arresting early childhood caries: a 6-months follow up of a randomized field trial. BMC Oral Health. 2023 Nov 17;23(1):875. doi: 10.1186/s12903-023-03597-5.
- 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.
Enas B Abdellatif, Bachelor principal investigator
Alexandria University
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 SDF and NaF 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 19 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?
The percentage of arrested carious lesions (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 NCT05642494, 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 19 Jul 2023.