Early Childhood Caries
Conditions
Keywords
ECC, SDF 38%, NaF 5%, preschoolers
Brief 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. 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.
Interventions
Sponsors
Science, Technology & Innovation Funding Authority (STDF)
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 4 Years
Healthy volunteers
No
Inclusion criteria
1. Children ≤ 4 years old. 2. 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. 3. The Carious lesion has to be active according to Lesion Activity criteria of coronal caries of ICDAS II. 4. Parental consent for children's participation in the study.
Exclusion criteria
1. Children reporting spontaneous or elicited pain from caries, or showing any signs of pulpal infection, swelling and/or abscess. 2. Children showing a definite negative behavior (Score 1 Frankel's classification) during clinical examination. 3. Allergy or sensitivity to silver or any of the materials included in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of arrested carious lesions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caries Increment (number of new caries lesions) | 6 months | 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). |
| Parental satisfaction with SDF application | Baseline and at 6 months | 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). |
| Adverse effects reported after application of the interventions | Baseline and at 6 months | Parents will be asked if their child experienced tooth or gum pain after application of the material. (Yes/No) Question |
Countries
Egypt
Outcome results
None listed