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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
Liverpool University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Orthodontic Appliance Complication focused on measuring Fluoride, CPP-ACP

Eligibility Criteria

11 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 10, 2021
    Last Updated
    November 23, 2022
    Sponsor
    Liverpool University Hospitals NHS Foundation Trust
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    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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