Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04816487 |
| Other study ID # |
Reducing discoloration of SDF |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
March 2021 |
| Source |
Cairo University |
| Contact |
Reem Hifni |
| Phone |
+201060600311 |
| Email |
reemhifni[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Although black staining is considered a drawback that is clinically observed following SDF
application and is the main primary barrier for its use clinically . Child's behaviour and
cooperation cannot be controlled at a young age or in special health care needs cases.
Therefore, the best treatment modality will always be a simple, fast and painless procedure
and SDF is the best solution for those cases. Discolouration caused researchers to search for
a solution that will reduce or prevent discolouration using KI and GSH. A systematic review
was conducted in-vitro, and it showed the use of SDF with KI had reduced stains markedly,
potential advantages of minimal staining might be advantageous, along a short period.
However, studies with long-term follow-up would be required to provide evidence-based
guidelines for using SDF and KI formulations in routine clinical practice
Description:
Early childhood caries (ECC) has been increasing worldwide and became a significant health
problem. ECC is a multifactorial disease result from the interaction of different factors as
cariogenic microorganisms, exposure to fermentable carbohydrates through inappropriate
feeding habits. It affects teeth that are less susceptible to caries. The management of ECC
is expensive, often requiring extensive restorative treatment such as the drill and fill
technique and extraction of teeth at an early age. Nowadays, non-invasive treatment for
arresting untreated dental caries is becoming urgently needed.
Silver diamine fluoride (SDF) treatment offers an alternative non-invasive treatment for
caries as it arrests caries progression. S.D.F. is a colourless agent in the form of liquid
with an alkaline PH of 10 it contains 24.4% to 28.8% (weight/volume) silver and 5.0 to 5.9%
fluoride .. SDF is inexpensive treatment, and its ease of the application makes it a durable
treatment option in dental clinics. Arresting active caries is an essential treatment
modality and requires training by all dental auxiliaries.
The major drawback to SDF treatment has been its black stain and discolouration, which has
limited its use. The precipitation of silver by-products in the dental tissues results in
black staining, which can be discouraging and limits its use in visible areas. SDF also
temporarily stains skin and gingiva, requiring them to be handled carefully to avoid contact
with these tissues. To overcome the staining, SDF researchers investigated applying a
saturated solution of potassium iodide (10% weight % KI) and studied the effect of
glutathione (GSH) biomolecule on reducing of enamel and dentin discolouration.
Potassium iodide (KI) is used as a nutritional supplement. A supersaturated solution of KI is
used in managing the discolouration problem of the carious lesion without affecting its
caries arresting effect. It reduces the staining caused by the SDF as silver ions from the
SDF solution reacts with the iodide ions present in KI solution, which results in the
formation of silver iodide.
Glutathione (GSH) is a tri-peptide biomolecule, and it is considered one of the best with
silver as it contains a thiol group (-SH) which has a high affinity for adsorption onto metal
surfaces . GSH also forms a coat around silver particles, decreasing the aggregation of
silver particles and controlling the rate of silver ion release (Homeostasis) , which reduces
the discolouration of an SDF-coated tooth over time. This study was conducted to compare the
effect of glutathione (GSH) versus Potassium iodide (KI) in reducing the SDF staining effect
in carious primary teeth.
