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

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03557996
• Other study ID #: CEBD-CU-2018-06-2
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2018
• Source: Cairo University
• Contact: Yousra M Abdel Rehim, MSc
• Phone: 01273335144
• Email: yousra.mohamed[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: June 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Drug:
• Silver Diamine Fluoride
SDF will be applied with a brush
• Sodium Fluoride Varnish
NaF will be applied with a brush

Locations

Country	Name	City	State
Egypt	Pediatric Dentistry, Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discoloration	Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)	12 months
Secondary	Investigator reported discoloration	Investigator will report the discoloration occurred to treated teeth (yellow, brown, black) Visual examination	12 months
Secondary	Timing of discoloration	Visual examination at follow up	12 months
Secondary	Caries arrest (dentine texture)	Caries arrest will be assessed through tactile examination (Soft or hard) Tactile examination	12 months
Secondary	Postoperative Pain: Questioning the patient	Questioning the patient and/or the parentBinary (yes or No)	12 months
Secondary	Parental satisfaction: Questioning the parent	Questioning the parent	12 months