Early Childhood Caries
Conditions
Brief summary
The study was conducted to evaluate the effectiveness of the biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.
Detailed description
Owing to the virulent nature of early childhood caries (ECC) and its consequences if left untreated, immediate intervention is indicated to control the condition. Barriers to intervention as young age, uncooperative patient behavior and lack of access to dental care are however, very common. The use of silver diamine fluoride as an anticaries agent is of growing popularity worldwide due to its promising results, safety of use, ease of application and relatively low cost. Further research is still required in order to provide evidence-based recommendations regarding the use of SDF in arresting early childhood caries. Purpose: To evaluate the effectiveness of biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.
Interventions
DRUGSDF
SDF promotes enamel and dentin remineralization, as well as inhibit the growth of cariogenic bacteria. the Food and Drug Administration (FDA) approved SDF as a device for reducing tooth sensitivity in the USA.
PROCEDUREART
The ART technique involves caries excavation by hand instruments only with care to avoid pulp exposure. Such excavation is mainly from the periphery of the lesion to achieve a good seal of the restoration and minimize leakage. The tooth is then restored by glass ionomer cement.
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* For children: 1. Healthy children. 2. Age range 2-5 years. 3. Informed consent (Appendix I) For teeth: * Teeth with active dentin lesions corresponding to ICDAS II score 5 and 6. * Teeth having lesions that are considered active according to ICDAS II activity criteria for coronal primary caries.
Exclusion criteria
* For children: 1. Children with systemic diseases. 2. Children with reported allergy to silver or to any other component in the materials used. 3. Children unable to return for recall visits. For teeth: * Clinical or radiographic signs of pulpal involvement.(pain, abscess, sinus, obvious discoloration, premature hypermobility, internal or external root resorption). * Teeth with inactive lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in clinical success/failure rate | at 6 and 12 months | Treated teeth in both groups will be evaluated for clinical success in each follow up appointment. The number of clinically successful/failed teeth will be recorded in |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the intervention visit | During the procedure | time spent during each intervention appointment was calculated in seconds |
| Patient Satisfaction | after the 4th week | using a 4-item, 5-level, Likert-scale questionnaire o assess feelings about the application procedure. |
Countries
Egypt
Outcome results
None listed