Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402500
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-15
Brief Title:
Color Masking Potential of Bioactive and ICON Materials
Sponsor:
King Abdullah University Hospital
Organization:
King Abdullah University Hospital
Study Overview
Official Title:
The Color Masking Potentials of a Bioactive Glass Adhesive and the Resin ICON on the White Spot Lesions A Comparative Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The non cavitated white-spot lesion WSL occurs after sometime during fixed orthodontic treatments and their treatment is mandatory before going into frank cavitation The resin infiltration material ICON DMG America is considered to be the gold standard resin infiltrationmaterial used for WSL treatment It is an efficient material in arresting WSLs and has high favorable esthetic recovery Furthermore biomaterials like bioactive glass adhesives HI-bond universal adhesive have always been used for replacement repair and generation of dental hard tissues The hypotheses of this study are
1 There will be no differences in color masking effect on WSLs managed by bioactive glass adhesive or ICON resin infiltration
2 There will be no significant addition of mineral content into WSLs after treating it with bioactive glass adhesive HI-Bond universal or with ICON
1 There will be no differences in color masking effect on WSLs managed by bioactive glass adhesive or ICON resin infiltration
2 There will be no significant addition of mineral content into WSLs after treating it with bioactive glass adhesive HI-Bond universal or with ICON
Detailed Description:
After sample size calculations were carried out a total sample size of 150 teeth will be included 75 teeth will be treated with ICON and 75 other teeth will be treated with HI-Bond universal
Split mouth study design involves treating WSLs in two different quadrants in each participant Treatments will be done according to manufacturers instruction The WSLs in the teeth of one quadrant will receive treatments with the ICON DMG America and the others in the opposite quadrant will receive treatments with the bioactive glass adhesive HI-Bond universal MEDICLUS south Korea
Before receiving the treatment the WSLs will be tested at baseline by Quantitative light-induced fluorescence QLF device then the test will be repeated at 1-month after the treatment for the quadrant that received bioactive glass adhesive
Split mouth study design involves treating WSLs in two different quadrants in each participant Treatments will be done according to manufacturers instruction The WSLs in the teeth of one quadrant will receive treatments with the ICON DMG America and the others in the opposite quadrant will receive treatments with the bioactive glass adhesive HI-Bond universal MEDICLUS south Korea
Before receiving the treatment the WSLs will be tested at baseline by Quantitative light-induced fluorescence QLF device then the test will be repeated at 1-month after the treatment for the quadrant that received bioactive glass adhesive
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None