Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316323
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish
Sponsor:
Universiti Teknologi Mara
Organization:
Universiti Teknologi Mara
Study Overview
Official Title:
The Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish on Salivary pH and Streptococcus Mutans and Lactobacillus in Early Childhood Caries A Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 763 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
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 763 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None