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| Name | Class |
|---|---|
| Science,Technology & Innovation Funding Authority, Egypt | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDF+NaF | Experimental | Silver Diamine fluoride 38% (Applied biannually)+ Sodium Fluoride Varnish 5% (Applied every 3 months) |
|
| SDF | Active Comparator | Silver Diamine fluoride 38% (Applied biannually) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDF | Device | Silver Diamine Fluoride 38% (Applied bianually) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enas B Abdellatif, Bachelor | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Of Dentistry Alexandria University | Alexandria | 21514 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37978488 | Derived | 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. |
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| NaF |
| Device |
Sodium Fluoride Varnish (5%) (Applied at baseline and after 3 months) |
|
| 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). | 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). | 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). | 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). | 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 | 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 | 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 | 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 | 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). | Baseline and at 6 months |