Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental Satisfaction

Khalood Saeed Bahammam

Status: Unknown

Conditions: Caries Arrested

Treatments: Other: Silver Diamine Fluoride (SDF)

Study type: Interventional

Funder types: Other

Identifiers

NCT04642846

IAU

Details and patient eligibility

About

Globally, it is estimated that 2.4 billion people suffer from caries of permanent teeth and 486 million children suffer from caries of primary teeth . The highest estimate of dental caries prevalence in Saudi Arabia was 95% with maximum DMFT of 7.34 among 3-7 years old children . Also, it was found that 78% of 6-9 years old children in Dammam had caries with an average of 3.66±3.13 DMFT.

The objectives of this study are:

1. To assess the effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
2. To assess the antibacterial effect of the Silver Diamine Fluoride (SDF).
3. To assess parents' and children's satisfaction and acceptance.

The aims of our study are to assess the effectiveness of SDF in arresting caries in primary dentition among children visiting Imam Abdulrahman bin Faisal University in Dammam, Saudi Arabia and to assess parental acceptance and satisfaction.

The expected outcome the results of this study will help in understanding the effectiveness SDF in arresting dental caries in this target population especially that it was recently approved for clinical use in Saudi Arabia.

Enrollment: 155 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children between four and six years of age.
• Healthy.
• Have at least two active dentin carious lesions on the primary teeth meeting the International Caries Detection and Assessment System (ICDAS) score 5 or 6.
• Should not have periapical infection, root resorption or widening in the periodontal ligament space.

Exclusion criteria

• Participants who have systemic or neurological diseases.
• Tooth abscess, pain on percussion, symptoms of pulpal involvement or mobility,
• Allergic to silver or any dental material to be used.
• Unable to attend follow-up visits.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 2 patient groups

one application of SDF

Experimental group

Treatment:

Other: Silver Diamine Fluoride (SDF)

two application of SDF one month apart

Experimental group

Treatment:

Other: Silver Diamine Fluoride (SDF)