Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738356
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2023-02-04
Brief Title:
Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems
Sponsor:
Jordan University of Science and Technology
Organization:
Jordan University of Science and Technology
Study Overview
Official Title:
Comparison of Three Orthodontic Bonding Systems in White Spot Lesion Development A Randomized Clinical Trial
Status:
COMPLETED
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 gaol of this randomized clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of white spot lesions WSLs during fixed orthodontic therapy in comparison with the conventional 3 step bonding system
All participants will be bonded with similar fixed orthodontic appliances using each type of adhesives for the assigned group WSLs will be monitored during the orthodontic treatment
All participants will be bonded with similar fixed orthodontic appliances using each type of adhesives for the assigned group WSLs will be monitored during the orthodontic treatment
Detailed Description:
Objectives The objective of this clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of WSLs during fixed orthodontic therapy in comparison with the conventional 3 step bonding system
Materials and Methods Seventy five patients were randomly allocated into 3 groups Group 1 conventional bonding system n25 Group 2 self-etch primer n25 Group 3 primer mixed with the adhesive composite n25 Quantitative light-induced fluorescence QLF was used to quantify WSL parameters Images were captured and then analyzed before treatment 2 months and 4 months after bond-up Lesion area Pixels mean fluorescence loss F and the number of newly developed WSLs were compared within and between the 3 groups The significance level was set at P 005
Materials and Methods Seventy five patients were randomly allocated into 3 groups Group 1 conventional bonding system n25 Group 2 self-etch primer n25 Group 3 primer mixed with the adhesive composite n25 Quantitative light-induced fluorescence QLF was used to quantify WSL parameters Images were captured and then analyzed before treatment 2 months and 4 months after bond-up Lesion area Pixels mean fluorescence loss F and the number of newly developed WSLs were compared within and between the 3 groups The significance level was set at P 005
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?:
True
Is an FDA AA801 Violation?:
None