NCT03557996

Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish

Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Accepted

Summary

To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish.

Detailed description

The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation. Benefit to the patient * No pain and infection. * Enhance child cooperation. * Enhance better patient compliance. * Decrease cost of dental treatment and may eliminate the need for General Anesthesia. Benefit to the dentist * Develop an effective fast easy method to arrest the caries by using SDF. * Ease of dental treatment. * Better cooperation with the child. * The procedure is simple. * Inexpensive and non-invasive. * It does not require expensive equipment or support infrastructure, such as pipe water or electricity. Benefit to the population * Reduce the harmful impact of oral health problems in preschool children from low income families. * SDF can be considered a user-friendly material for use in dental clinics as well as remote areas, schools or deprived communities. Children aged 2-5 years can benefit from the use of SDF, an easy anticaries treatment. Furthermore, children in this age group may benefit from delayed dental treatment and overall caries arrest, thus reducing potential pain and infection, expensive future emergency room visits, the need for general anesthesia or traumatic dental experiences on uncooperative children.

Conditions

• Dental Caries in Children

Interventions

Type	Name	Description
DRUG	Silver Diamine Fluoride	SDF will be applied with a brush
DRUG	Sodium Fluoride Varnish	NaF will be applied with a brush

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-11-01
• Completion: 2020-06-01
• First posted: 2018-06-15
• Last updated: 2018-06-18

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study