Fluoride Delivery to Prevent White Spots During Orthodontic Treatment (FL4OWS)

A Randomised, Controlled Trial to Assess the Effect of Different Modes of Fluoride Delivery on Enamel Demineralisation, During Orthodontic Treatment With Fixed Appliances

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.

Study Overview

• Status: Recruiting
• Conditions: Tooth Demineralization; Orthodontic Appliance Complication
• Intervention / Treatment: Drug: Fluoride mouthwash (0.05%; 225ppm).; Drug: Tooth Mousse Plus

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jayne E Harrison, FDS, PhD; Phone Number: 441517065030; Email: Jayne.Harrison@liverpoolft.nhs.uk
• Study Contact Backup: Name: Norah L Flannigan, FDS, PhD; Phone Number: 441517065210; Email: NLF@liverpool.ac.uk

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L9 7AL
      • Recruiting
      • Liverpool University Hospitals NHS Foundation Trust
      • Contact: Jayne Harrison; Phone Number: 0151 525 5980; Email: jayne.harrison@liverpoolft.nhs.uk
      • Principal Investigator: Jayne Harrison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mouthwash; Fluoride mouthwash (0.05%; 225ppm) 10ml for 1 minute daily	Drug: Fluoride mouthwash (0.05%; 225ppm).; Mouthwash; Other Names: Fluorigard
Experimental: Tooth Mousse; 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	Drug: Tooth Mousse Plus; Tooth Mousse; Other Names: Recaldent™ CPP-ACP [casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP)] and Sodium Fluoride 0.2% w/w (900 ppm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through to study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through to study completion, an average of 2 years
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.	Through to study completion, an average of 2 years
Participants' perception of WSL	Participants' perception of the WSLs. Measured on 100mm visual analogue scale (VAS). Scale 0 to 100. Higher score is worse.	Through to study completion, an average of 2 years
Parents' perception of WSL	Parents' perception of the WSLs. Measured on 100mm visual analogue scale (VAS). Scale 0 to 100. Higher score is worse.	Through to study completion, an average of 2 years
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).	Through to study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Liverpool University Hospitals NHS Foundation Trust
• Investigators: Study Chair: Heather Rogers, Liverpool University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Fluoride; CPP-ACP
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Sodium Fluoride
• Other Study ID Numbers: 5604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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