Fluoride Delivery to Prevent White Spots During Orthodontic Treatment (FL4OWS)
Primary Purpose
Orthodontic Appliance Complication, Tooth Demineralization
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fluoride mouthwash (0.05%; 225ppm).
Tooth Mousse Plus
Sponsored by
About this trial
This is an interventional prevention trial for Orthodontic Appliance Complication focused on measuring Fluoride, CPP-ACP
Eligibility Criteria
Inclusion Criteria:
- Planned to receive orthodontic treatment with upper and lower fixed orthodontic appliances (braces) either alone or following a period of functional appliance treatment.
- 11-16 years of age inclusive at the start of the fixed orthodontic appliance treatment.
- All genders.
- Fit and well with no chronic disease necessitating regular hospital follow-up at hospital.
- Willing to participate
Exclusion Criteria:
- Significant disabilities that may affect manual dexterity;
- Any medical complication that would contraindicate the use of the fluoride treatments or milk products;
- Previous orthodontic treatment except Phase I functional appliance treatment;
- From areas that have fluoridated water supply*;
- Full coronal coverage restorations;
- More than 2 missing anterior teeth;
- Showing signs of systemic illness e.g. fever, cough, loss of taste/smell;
- Any abnormality of face, lips e.g. cleft lip and/or palate or craniofacial abnormality or soft tissues of the mouth e.g. aphthous ulcers or connective tissue disorder.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mouthwash
Tooth Mousse
Arm Description
Fluoride mouthwash (0.05%; 225ppm) 10ml for 1 minute daily
Tooth Mousse Plus (Recaldent™ CPP-ACP [casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP)] and Sodium Fluoride 0.2% w/w; 900 ppm). Tooth creme; 2ml smear daily
Outcomes
Primary Outcome Measures
New white spot lesions (WSLs)
The incidence of new demineralisation (WSLs), developing on the anterior teeth during fixed orthodontic treatment assessed from white light and quantitative light-induced fluorescence (QLF) images, will be measured.
Numerical scale 0 - unlikely to be more than 100. Higher score is worse.
Secondary Outcome Measures
Size of white spot lesion (WSL)
The degree (∆F) of enamel demineralisation on the surfaces of the anterior teeth measure from quantitative light-induced fluorescence (QLF) images.
Measured as a percentage (%) compared to baseline i.e. loss of mineral. Scale ∆F 0% to -100%; Higher score is worse.
Extent of white spot lesion (WSL)
The extent (∆Q) of enamel demineralisation on the surfaces of the anterior teeth. measure from quantitative light-induced fluorescence (QLF) images.
Measured as a percentage per millimetre squared (%mm-2) compared to baseline i.e. loss of mineral. Scale ∆Q 0% to -100%mm-2. Higher score is worse.
Participants' perception of WSL
Participants' perception of the WSLs. Measured on 100mm visual analogue scale (VAS). Scale 0 to 100. Higher score is worse.
Parents' perception of WSL
Parents' perception of the WSLs. Measured on 100mm visual analogue scale (VAS). Scale 0 to 100. Higher score is worse.
MIQ Score
Malocclusion Impact Questionnaire (MIQ) score. Measured using a 17-item questionnaire.
Total score will be used where minimum score is 0 and maximum score is 34; higher score indicates poorer oral health related quality of life (OHRQoL).
Full Information
NCT ID
NCT05005689
First Posted
June 10, 2021
Last Updated
November 23, 2022
Sponsor
Liverpool University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05005689
Brief Title
Fluoride Delivery to Prevent White Spots During Orthodontic Treatment
Acronym
FL4OWS
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2022 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool University Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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:
Fluoride mouth wash (Fluorigard) or
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Appliance Complication, Tooth Demineralization
Keywords
Fluoride, CPP-ACP
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mouthwash
Arm Type
Active Comparator
Arm Description
Fluoride mouthwash (0.05%; 225ppm) 10ml for 1 minute daily
Arm Title
Tooth Mousse
Arm Type
Experimental
Arm Description
Tooth Mousse Plus (Recaldent™ CPP-ACP [casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP)] and Sodium Fluoride 0.2% w/w; 900 ppm).
Tooth creme; 2ml smear daily
Intervention Type
Drug
Intervention Name(s)
Fluoride mouthwash (0.05%; 225ppm).
Other Intervention Name(s)
Fluorigard
Intervention Description
Mouthwash
Intervention Type
Drug
Intervention Name(s)
Tooth Mousse Plus
Other Intervention Name(s)
Recaldent™ CPP-ACP [casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP)] and Sodium Fluoride 0.2% w/w (900 ppm).
Intervention Description
Tooth Mousse
Primary Outcome Measure Information:
Title
New white spot lesions (WSLs)
Description
The incidence of new demineralisation (WSLs), developing on the anterior teeth during fixed orthodontic treatment assessed from white light and quantitative light-induced fluorescence (QLF) images, will be measured.
Numerical scale 0 - unlikely to be more than 100. Higher score is worse.
Time Frame
Through to study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Size of white spot lesion (WSL)
Description
The degree (∆F) of enamel demineralisation on the surfaces of the anterior teeth measure from quantitative light-induced fluorescence (QLF) images.
Measured as a percentage (%) compared to baseline i.e. loss of mineral. Scale ∆F 0% to -100%; Higher score is worse.
Time Frame
Through to study completion, an average of 2 years
Title
Extent of white spot lesion (WSL)
Description
The extent (∆Q) of enamel demineralisation on the surfaces of the anterior teeth. measure from quantitative light-induced fluorescence (QLF) images.
Measured as a percentage per millimetre squared (%mm-2) compared to baseline i.e. loss of mineral. Scale ∆Q 0% to -100%mm-2. Higher score is worse.
Time Frame
Through to study completion, an average of 2 years
Title
Participants' perception of WSL
Description
Participants' perception of the WSLs. Measured on 100mm visual analogue scale (VAS). Scale 0 to 100. Higher score is worse.
Time Frame
Through to study completion, an average of 2 years
Title
Parents' perception of WSL
Description
Parents' perception of the WSLs. Measured on 100mm visual analogue scale (VAS). Scale 0 to 100. Higher score is worse.
Time Frame
Through to study completion, an average of 2 years
Title
MIQ Score
Description
Malocclusion Impact Questionnaire (MIQ) score. Measured using a 17-item questionnaire.
Total score will be used where minimum score is 0 and maximum score is 34; higher score indicates poorer oral health related quality of life (OHRQoL).
Time Frame
Through to study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Planned to receive orthodontic treatment with upper and lower fixed orthodontic appliances (braces) either alone or following a period of functional appliance treatment.
11-16 years of age inclusive at the start of the fixed orthodontic appliance treatment.
All genders.
Fit and well with no chronic disease necessitating regular hospital follow-up at hospital.
Willing to participate
Exclusion Criteria:
Significant disabilities that may affect manual dexterity;
Any medical complication that would contraindicate the use of the fluoride treatments or milk products;
Previous orthodontic treatment except Phase I functional appliance treatment;
From areas that have fluoridated water supply*;
Full coronal coverage restorations;
More than 2 missing anterior teeth;
Showing signs of systemic illness e.g. fever, cough, loss of taste/smell;
Any abnormality of face, lips e.g. cleft lip and/or palate or craniofacial abnormality or soft tissues of the mouth e.g. aphthous ulcers or connective tissue disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jayne E Harrison, FDS, PhD
Phone
441517065030
Email
Jayne.Harrison@liverpoolft.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Norah L Flannigan, FDS, PhD
Phone
441517065210
Email
NLF@liverpool.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Rogers
Organizational Affiliation
Liverpool University Hospitals NHS Foundation Trust
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fluoride Delivery to Prevent White Spots During Orthodontic Treatment
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