Silver Diamine Fluoride Effectiveness Versus Atraumatic Restorative Treatment in Arresting ECC

Early Childhood Caries Clinical Trial

Official title:

Effectiveness of Silver Diamine Fluoride in Arresting Early Childhood Caries: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514094
• Other study ID #: SDF Trials
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 23, 2019

Study information

• Verified date: August 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 23, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Drug:
• SDF
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.

Procedure:
• ART
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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 6 and 12 months
Secondary	Duration of the intervention visit	time spent during each intervention appointment was calculated in seconds	During the procedure
Secondary	Patient Satisfaction	using a 4-item, 5-level, Likert-scale questionnaire o assess feelings about the application procedure.	after the 4th week