Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05240365 |
| Other study ID # |
SDF Modified Hall |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2022 |
| Est. completion date |
June 2023 |
Study information
| Verified date |
January 2022 |
| Source |
Cairo University |
| Contact |
Sondos A Naserallah, B.D.S |
| Phone |
01141004620 |
| Email |
sondos.ahmed[@]dentistry.cu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Dental caries in primary teeth is considered the most common oral disease of childhood and it
has been investigated in many places throughout the world. In most developed countries, the
prevalence of early childhood caries (ECC) ranges between 1% and 12%. In less developed
countries, however, the prevalence is much higher, exceeding 70%.
Pulpotomy is a clinical procedure usually performed in primary molars with extensive caries,
which implies removal of the coronal pulp and preservation of the radicular pulp. It is based
on the ability of the remaining pulp tissue to heal after the affected or infected coronal
pulp has been surgically removed. Pulpotomy is a technique that is highly dependent on a
number of factors, including diagnosis accuracy, caries excavation method, pulp dressing
material, final restoration quality and operator experience.
Silver diamine fluoride (SDF) has recently become a non-invasive treatment option, it is
fluid-form material used in prevention and treatment of teeth cavities (or caries). SDF has
been demonstrated to be useful in arresting caries development after a cavity has formed. In
hundreds of studies, the only common side effect of SDF has been black staining surrounding
the area. SDF has the ability to stain anything it comes into contact with, including
clothing and oral tissues.
Hall technique is a method for management primary molar decay that involves the use of
preformed metal crowns (PMCs) to seal decay. This technique may be able to stop or at least
reduce caries progression in primary teeth. The process of fitting the crown is quick and
non-invasive.
Description:
Dental caries is the most common childhood disease and the most common health issue
worldwide, despite a half-century of concerted clinical and public health efforts to
eliminate it.Untreated caries causes health issues such as pain, poor quality of life,
psychosocial suffering, as well as societal burdens such as reduced productivity at work and
school.
In order to reduce disease incidence and burden, meet population-level oral health goals, and
address patient concerns, oral health education, home hygiene, avoidance of fermentable
carbohydrates, consumption of fluoridated water, and access to and utilization of routine
dental screenings, examinations, and care are all critical. Caries prevention and treatment
strategies that are safe, easy, effective, low-cost, minimally invasive, and amenable to a
variety of community settings are desired by dental public health and oral health
stakeholders.
One of the traditional methods of managing carious primary molars in children is conventional
pulpotomy with stainless steel crowns (SSCs). Recently, other treatments are being used as
silver diamine fluoride (SDF) and the Hall technique.
Primary teeth pulpotomy is defined as amputation of the coronal pulp and treatment of the
remaining vital radicular portion with a long term clinically successful medicament. An ideal
medicament used for pulpotomy should have a bactericidal effect, enhance healing of the
radicular pulp tissue and biocompatible then using an accurate size of stainless steel crown.
Hall technique is one of the most common methods for sealing caries in primary molars
nowadays. Dr. Norna Hall, a general dentist from Scotland, originally described Hall
technique using preformed metal crowns (PMCs) in the literature in 2006. It has very
straightforward biological principles. It can protect the primary tooth till shedding and
arrest caries. The superficial plaque layer, which is the most essential element in the
biofilm for caries growth, is left and sealed together with the carious lesion when using
Hall technique. As a result, the plaque biofilm flora will be changed to be less cariogenic
that may arrest or reduce the progression of caries in primary teeth.
SDF has been proven to be effective in caries arrest. It's used to manage early childhood
caries. Silver and fluoride ions combine to form SDF, a colorless ammonia solution. The
fluoride in SDF has a long history of exaggerating enamel and dentine remineralization, while
silver has been shown to have potent antimicrobial properties.
