Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403371
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-16
Brief Title:
The Effect of Fluoride Varnish on White Spot Lesion in Clear Aligner Orthodontic Patients
Sponsor:
King Abdullah University Hospital
Organization:
King Abdullah University Hospital
Study Overview
Official Title:
The Effect of Fluoride Varnish on White Spot Lesion in Clear Aligner Orthodontic Patients Prospective Randomized Controlled Clinical Trial
Status:
ACTIVE_NOT_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:
Fluoride varnish is being applied on the teeth surfaces of patients undergoing orthodontic treatment just before receiving their clear aligners The effect of the varnish was investigated if it can reduce the incidence of enamel demineralization or not
Detailed Description:
Background The preventive effect of fluoride varnish on the development of white spot lesions WSLs during clear aligner treatment has not been investigated in the literature Hence this was the purpose of this study Material and Methods This was a prospective double-blinded randomized clinical trial A total of 44 patients 7 males 37 females with a mean age of 2091 456 who sought clear aligner therapy at the postgraduate orthodontic clinics at JUST were recruited and randomly divided equally n22 in each group by a website randomizer Eligibility criteria included healthy patients of both sexes age range 14-30 years Class I malocclusion with mild-to-moderate crowding 5 mm non-extraction treatment plan and optimum oral hygiene before treatment Both the patient and the investigator were blinded during the intervention and assessment of outcomes At T0 Fluoride varnish was applied to the subjects in Group 1 while normal saline was applied to the subjects in Group 2 as a control Quantitative light-induced fluorescence QLF images were taken at the start of the treatment T0 and after 4 months T1 The QLF images were analyzed to assess the primary outcomes lesion area Pixels the mean amount of fluorescence loss ΔF in addition to the number of newly developed lesions
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