The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish

NCT06316323 | Completed Phase 1 FDA Drug

• 1 other identifier: REC/09/2021 (FB/51)
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Sodium Fluoride (NAF) varnish was considered as the treatment of Early Childhood Caries (ECC). However, the emergence of Silver Diamine Fluoride (SDF) has become more popular to tackle dental caries among children. SDF has silver ions that harbor antibacterial properties that play a crucial role in arresting active, cavitated carious lesions and has fluoride ions that are important in remineralizing enamel and dentin. This randomized control trial aims to compare the effect of SDF and NaF varnish on the salivary pH and density of Streptococcus mutans and Lactobacillus. 49 subjects below 6 years old, attending dental treatment at the Faculty of Dentistry, Universiti Teknologi MARA (UiTM) were recruited and were divided into two groups of treatment: 38% SDF or 5% SDF. Saliva samples of each subject were collected to test for salivary pH and density of S. mutans and Lactobacillus before the treatment and after 3 months of treatment. The salivary pH were tested using a calibrated pH meter. Saliva samples were subjected to microbiological analysis using Colony Forming Unit (CFU) and quantitative Polymerase Chain Reaction (qPCR) technique. The findings of this study will be used to support the use of SDF as an alternative to NaF varnish and to develop a recommendation guideline on the clinical use of SDF in ECC management.

Conditions

Early Childhood Caries

Keywords

silver diamine fluoride; fluoride varnish; early childhood caries

Outcome Measures

Primary Outcomes (3)

• comparison of salivary pH

  to compare the salivary pH before and after 3 months of 38% SDF and 5% NaF treatment

  3 months

• comparison of salivary counts of Streptococcus mutans

  to compare the salivary counts of Streptococcus mutans before and after 3 months of 38% SDF and 5% NaF treatment

  3 months

• comparison of salivary counts of Lactobacillus

  to compare the salivary counts of Lactobacillus before and after 3 months of 38% SDF and 5% NaF treatment

  3 months

Secondary Outcomes (1)

• Detection and comparison of salivary counts of Lactobacillus acidophilus

  3 months

Study Arms (2)

Group A

EXPERIMENTAL

Silver Diamine Fluoride

Drug: Silver diamine fluoride

Group B

EXPERIMENTAL

Sodium Fluoride Varnish

Drug: Sodium fluoride

Interventions

Silver diamine fluoride DRUG

38% Silver Diamine Fluoride (SDF) is a topical antimicrobial and remineralizing agent which was cleared by the FDA as a Class II medical device to treat tooth sensitivity. In certain circumstances, SDF may be used as a non-restorative treatment to arrest carious lesions on primary and permanent teeth

Also known as: SDF

Group A

Sodium fluoride DRUG

Fluoride varnish to apply on tooth surface, so that the tooth becomes more resistant to caries attack. The active ingredient of fluoride varnish is 5% sodium fluoride, (22,600 ppm fluoride)

Also known as: NaF

Group B

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children under 6 years old, with ECC, having at least one active dentinal caries were included in this study. The cavitated tooth was assessed using International Caries Detection and Assessment System (ICDAS). Children that only had the tooth that fulfilled the ICDAS score 5 were included. This is characterized by a distinct cavity with visible dentine, not including more than half of the tooth. The tooth must not be mobile, associated with abscess, or have the symptoms of irreversible pulpitis. Children that had been included in this study must have not been on antibiotic treatment for at least 3 months before the start of the study and not being put on such treatment throughout the study period

Sponsors & Collaborators

• Universiti Teknologi Mara: lead

Study Sites (1)

University Technology MARA

Sungai Buloh, Selangor, 47000, Malaysia

Location

MeSH Terms

Interventions

silver diamine fluoride; Sodium Fluoride

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• NUR ASMAD, BDS, MScD

  University Technology MARA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Subjects that participated in this study were randomly allocated to two groups; Group A and Group B. Group A subjects were treated with 38% SDF and Group B subjects were treated with 5% NaF varnish. The randomisations of the subjects were done using a sealed envelope. Sequentially numbered, opaque sealed envelopes (SNOSE) method was used for the allocation concealments. This study was conducted in a non-blinded manner, as it was deemed impossible to blind the subjects. The treatment solutions utilized in this study were clearly distinct, with the SDF solution comprising a two-step process, while NaF varnish only required a single step. Additionally, the treatments exhibited different colors and textures. Consequently, the principal investigator had to closely supervise the treatment of each group. Due to the risk of blackish staining associated with SDF, parents and children were not blinded and were informed of the treatment they would receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: one group received silver diamine fluoride treatment, and another group received sodium fluoride varnish treatment

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: February 1, 2023
• Primary Completion: September 29, 2023
• Study Completion: January 26, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)