Silver Diamine Fluoride Effectiveness Versus Atraumatic Restorative Treatment in Arresting ECC

Hams Hamed Abdelrahman100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Early Childhood Caries

Interventions

SDFDRUG

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.

ARTPROCEDURE

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

change in clinical success/failure rate

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

Time frame: at 6 and 12 months

Secondary Outcomes

Duration of the intervention visit

time spent during each intervention appointment was calculated in seconds

Time frame: During the procedure

Patient Satisfaction

using a 4-item, 5-level, Likert-scale questionnaire o assess feelings about the application procedure.

Time frame: after the 4th week

Data from ClinicalTrials.gov

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