Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04560478
Status:
COMPLETED
Last Update Posted:
2020-09-23
First Post:
2020-09-17
Brief Title:
Comparing Fluoride Varnish and Sealant to Prevent White Spots in Orthodontic Patients
Sponsor:
Texas AM University
Organization:
Texas AM University
Study Overview
Official Title:
THE EFFICACY OF MI VARNISH VERSUS PRO SEAL SEALANT ON PREVENTION OF WHITE SPOT LESIONS IN ORTHODONTIC PATIENTS A RANDOMIZED CLINICAL TRIAL
Status:
COMPLETED
Status Verified Date:
2020-09
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 purpose of the study is o compare the efficacy of CPP-ACP MI Varnish and ProSeal sealant in preventing white spot lesion WSL formation in orthodontic patients
Detailed Description:
This prospective randomized clinical trial included 40 orthodontic patients between the ages of 12-17 who were randomly allocated to two groups Group 1 Sealant Group received sealant on the maxillary anterior canines lateral incisors and central incisors with reapplication of the sealant every 3 months Group 2 Varnish Group had MI Varnish applied every 4-6 weeks without sealant placed on the maxillary anterior teeth White spot lesion formation was evaluated with standardized digital photographs at two timepoints T1 initial appointment before bonding and T2 12 months later with brackets removed The brackets were removed in order to facilitate an adequate photographic exam Photographs were analyzed side-by-side at the conclusion of the study with the Enamel Decalcification Index EDI The location of WSLs were recorded by tooth type and by region Oral hygiene was evaluated at T1 and T2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None