Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05005689
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2021-06-10
Brief Title:
Fluoride Delivery to Prevent White Spots During Orthodontic Treatment
Sponsor:
Liverpool University Hospitals NHS Foundation Trust
Organization:
Liverpool University Hospitals NHS Foundation Trust
Study Overview
Official Title:
A Randomised Controlled Trial to Assess the Effect of Different Modes of Fluoride Delivery on Enamel Demineralisation During Orthodontic Treatment With Fixed Appliances
Status:
RECRUITING
Status Verified Date:
2023-11
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:
FL4OWS
Brief Summary:
The aim of this 2-armed parallel randomised controlled trial is to assess the effect of different ways of applying fluoride to teeth on the formation of white spots enamel demineralisation during orthodontic treatment with fixed metal braces in children and adolescents
Detailed Description:
One of the most common side-effects and risks of orthodontic treatment with fixed metal braces is damage to the outer surface enamel of the teeth This damage can take the form of white or brown spots on the teeth white spot lesions WSLs or if severe holes in the teeth that need a filling
The aims of this study are to find out the best way of preventing damage to the teeth of children and adolescents who are under going orthodontic treatment with fixed metal braces
The participants will be 130 children aged 11-16 years old inclusive The participants will be split into two groups using a process called randomisation The treatments will be standard fluoride toothpaste Colgate and either
1 Fluoride mouth wash Fluorigard or
2 Tooth Mousse Plus
The participants teeth will be checked at every visit and the brace adjusted Photographs of the participants teeth will be taken very 3 months to see if any of the teeth have been damaged The participants will be asked about the impact of their teeth on their life Participants and parents will be asked about the impact of any white spots that form on the participants teeth during the treatment with fixed metal braces
The study will follow the participants through the whole length of treatment which will take about 2 years
The aims of this study are to find out the best way of preventing damage to the teeth of children and adolescents who are under going orthodontic treatment with fixed metal braces
The participants will be 130 children aged 11-16 years old inclusive The participants will be split into two groups using a process called randomisation The treatments will be standard fluoride toothpaste Colgate and either
1 Fluoride mouth wash Fluorigard or
2 Tooth Mousse Plus
The participants teeth will be checked at every visit and the brace adjusted Photographs of the participants teeth will be taken very 3 months to see if any of the teeth have been damaged The participants will be asked about the impact of their teeth on their life Participants and parents will be asked about the impact of any white spots that form on the participants teeth during the treatment with fixed metal braces
The study will follow the participants through the whole length of treatment which will take about 2 years
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