Orthodontic Appliance ComplicationPhase 4FL4OWSNCT05005689
Fluoride Delivery to Prevent White Spots During Orthodontic Treatment
A Phase 4 study testing Fluoride mouthwash (0.05%; 225ppm). and Tooth Mousse Plus in people with Orthodontic Appliance Complication and Tooth Demineralization, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Orthodontic Appliance Complication, Tooth Demineralization
- What is being tested?
- Fluoride mouthwash (0.05%; 225ppm). and Tooth Mousse Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2023to 30 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool, Merseyside, L9 7AL
Jayne Harrison, 0151 525 5980, jayne.harrison@liverpoolft.nhs.uk
Jayne Harrison
About this study
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
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.
Read the 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.
- Being tested
- Fluoride mouthwash (0.05%; 225ppm)., Tooth Mousse Plus
- Keywords
- Fluoride, CPP-ACP
- Medical subject headings
- Tooth Demineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride mouthwash (0.05%; 225ppm).Drug
Also called Fluorigard
Mouthwash
Tooth Mousse PlusDrug
Also called Recaldent™ CPP-ACP [casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP)] and Sodium Fluoride 0.2% w/w (900 ppm).
Tooth Mousse
| Study group | Role | What they receive |
|---|---|---|
| Mouthwash | Active comparator | Fluoride mouthwash (0.05%; 225ppm) 10ml for 1 minute daily Receives: Drug: Fluoride mouthwash (0.05%; 225ppm). |
| Tooth Mousse | Experimental | 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 Receives: Drug: Tooth Mousse Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through to study completion, an average of 2 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Through to study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start20 Oct 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Heather Rogers, Study chair, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005689
- Sponsor's protocol ID
- 5604
- Acronym
- FL4OWS
- Status last verified
- Nov 2023
- First submitted
- 10 Jun 2021
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05005689
- Acronym / sponsor ID
- FL4OWS / 5604
- Keywords
- Fluoride, CPP-ACP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mouthwash | Active comparator | Drug: Fluoride mouthwash (0.05%; 225ppm).Fluoride mouthwash (0.05%; 225ppm) 10ml for 1 minute daily |
| Tooth Mousse | Experimental | Drug: Tooth Mousse PlusTooth 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 |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride mouthwash (0.05%; 225ppm).Also: FluorigardMouthwash | Drug | Mouthwash |
| Tooth Mousse PlusAlso: Recaldent™ CPP-ACP [casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP)] and Sodium Fluoride 0.2% w/w (900 ppm).Tooth Mousse | Drug | Tooth Mousse |
Primary outcome
New white spot lesions (WSLs)
Time frame: Through to study completion, an average of 2 years
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.
5 secondary outcomes
Size of white spot lesion (WSL)
Time frame: Through to study completion, an average of 2 years
Extent of white spot lesion (WSL)
Time frame: Through to study completion, an average of 2 years
Participants' perception of WSL
Time frame: Through to study completion, an average of 2 years
Parents' perception of WSL
Time frame: Through to study completion, an average of 2 years
MIQ Score
Time frame: Through to study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Rogers study chair
Liverpool University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoride mouthwash (0.05%; 225ppm). and Tooth Mousse Plus in people with Orthodontic Appliance Complication and Tooth Demineralization, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayne E Harrison, FDS, PhD (441517065030, Jayne.Harrison@liverpoolft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New white spot lesions (WSLs) (time frame: Through to study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.