Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05948228 |
Other study ID # |
Giomer based bioactive gel |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 1
|
First received |
|
Last updated |
|
Start date |
August 2023 |
Est. completion date |
January 2025 |
Study information
Verified date |
July 2023 |
Source |
Cairo University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
white spot lesions are a common problem and are reported in up to 96% of orthodontic
patients. In this study, the preventive effect of bioactive gel is evaluated in comparison to
fluoride.
Description:
Dental caries is a chronic infectious disease present worldwide and is among one of the most
common oral diseases. It is a multifactorial disease resulting from imbalance between
demineralization and remineralization initiated by acid producing bacteria in the
microenvironment.
The incipient form of caries, white spot lesions (WSL), is characterized by primitive enamel
surface and subsurface demineralization and could be identified clinically by their chalky
white appearance . Orthodontic treatment is a major risk factor for the development of WSL.
They are reported in up to 96% of orthodontic patients.
Many materials are being used to prevent white spot lesions with fluoride being the most
commonly used . New materials have been emerged such as giomer based bioactive gel with the
ability to release six ions Fluoride inhibits demineralization and promotes deposition of
fluoroapatite. Aluminum helps to decrease demineralization as well by forming Alumino fluoro
complexes. Borate reduces biofilm formation beside its antibacterial effect.
Silica promotes remineralization by inducing apatite nucleation on the tooth surface.
Strontium converts hydroxyapatite into strontium apatite thus increasing acid resistance and
has an inhibitory effect on bacterial growth. Other ions such as Na act as strong base and
have acid buffer capacity.