- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06316323
The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Selangor
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Sungai Buloh, Selangor, Malaysia, 47000
- University Technology MARA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Exclusion Criteria:
- Children with any severe medical conditions, emotional or physical disorders were excluded from the study. Children that had been using chlorhexidine mouthwashes within 2 weeks before the baseline appointment or professional topical fluoride was applied in the past 6 months were also excluded. Another exclusion criteria are children that had gingival or perioral ulceration or stomatitis, or a tooth abscess, have a history of chemical allergies to silver, fluoride, potassium, iodine, and ammonia, and uncooperative child. Besides that, parents and children that were refused any type of treatment were excluded. Children who did not complete the follow up were considered dropouts.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
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
Other Names:
|
Experimental: Group B
Sodium Fluoride Varnish
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comparison of salivary pH
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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
Time Frame: 3 months
|
to compare the salivary counts of Lactobacillus before and after 3 months of 38% SDF and 5% NaF treatment
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection and comparison of salivary counts of Lactobacillus acidophilus
Time Frame: 3 months
|
to compare the relative numbers of Lactobacillus acidophilus before and after 3 months of 38% SDF and 5% NaF treatment with qPCR
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: NUR ASMAD, BDS, MScD, University Technology MARA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/09/2021 (FB/51)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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