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

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Dental Caries in Children

Treatments: Drug: Silver Diamine Fluoride; Drug: Sodium Fluoride Varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT03557996

CEBD-CU-2018-06-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Children with carious primary teeth before eruption of permanent teeth
2. High caries risk patients with anterior or posterior carious lesions
3. Uncooperative children without access to or with difficulty accessing dental care.

Exclusion criteria

1. Children with spontaneous or elicited pain from caries
2. Tooth mobility
3. Signs of pulpal infection
4. Severe medical conditions that would not allow management in the clinic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Group 1

Experimental group

Description:

38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up as 0,1,3,6,9 and 12 SDF is brush on liquid

Treatment:

Drug: Silver Diamine Fluoride

Group 2

Active Comparator group

Description:

5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12

Treatment:

Drug: Sodium Fluoride Varnish