The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish

NCT ID: NCT06316323

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-01-26

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.

Detailed Description

ECC continues to become a significant oral health concern owing to its high prevalence worldwide despite the preventive measures taken, including excessive oral health promotion. While conventional tooth restoration has been widely accepted as a standard intervention in managing ECC, the traumatic effects it causes may lead to dental fear, which prevents children from receiving dental treatment and subsequently leads to caries sequelae and complications. There is well-established evidence-based research proving the benefits of fluoride-based products in preventing dental caries. Previously, caries prevention in ECC was widely considered to be due to sodium fluoride (NaF) varnish. However, a systematic review found that treating dental caries with 5% NaF varnish is insufficient, urging the need to find another solution that is effective in halting caries progression.

In recent years, there has been great interest in the use of Silver Diamine Fluoride (SDF) as a new method for caries prevention because of its superior effects. The utilisation of SDF eliminates the necessity for tooth drilling, and it possesses anticariogenic properties that are essential for curbing active and cavitated carious lesions by rebuilding enamel and dentin. Existing data indicate that employing a non-invasive method of applying SDF with a 38% concentration twice a year can effectively manage ECC by up to 76.3% after a 30-month follow-up period. The application of 38% SDF has been demonstrated to significantly reduce the occurrence of new caries in treated children by approximately 77% compared with non-treated children.

Although various mechanisms underlying the antibacterial effects of SDF have been elucidated, data on its effects on salivary pH and cariogenic bacteria, particularly S. mutans and Lactobacillus, are lacking. Although several in vivo studies have explored the effect of SDF on S. mutans and Lactobacillus, the scarcity of clinical investigations remains a challenge. This study provides a better understanding of the effects of SDF on the modulation of salivary pH and S. mutans and Lactobacillus and provides scientific evidence on the mechanism of action of SDF in the oral environment. Therefore, this study is crucial to support the use of SDF in clinical settings as an alternative to the conventional method of treatment in managing ECC. To date, there is no clinical data regarding the use of SDF in Malaysia or the investigation of cariogenic bacterial profiling following SDF treatment among the Malaysian population. therefore the general research objective is to compare the effects of 38% SDF and 5% NaF on salivary pH, S. mutans, and Lactobacillus counts in children with ECC.

Conditions

Early Childhood Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Silver Diamine Fluoride

Group Type: EXPERIMENTAL

Silver diamine fluoride

Intervention Type: 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

Group B

Sodium Fluoride Varnish

Group Type: EXPERIMENTAL

Sodium fluoride

Intervention Type: 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)

Interventions

Silver diamine fluoride

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

Intervention Type: DRUG

Sodium fluoride

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)

Intervention Type: DRUG

Other Intervention Names

SDF; NaF

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Teknologi Mara

OTHER

Sponsor Role: lead

Responsible Party

Nur Amalina Asmad

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

NUR ASMAD, BDS, MScD

Role: PRINCIPAL_INVESTIGATOR

University Technology MARA

Locations

University Technology MARA

Sungai Buloh, Selangor, Malaysia

Countries

Malaysia

Other Identifiers

REC/09/2021 (FB/51)

Identifier Type: -

Identifier Source: org_study_id