Clinical trial NCT05005689: Fluoride Delivery to Prevent White Spots During Orthodontic Treatment
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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Orthodontic Appliance Complication
Tooth Demineralization
Keywords: Fluoride
CPP-ACP
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2021-08-13
Enrollment: 130
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: New white spot lesions (WSLs)
timeFrame: Through to study completion, an average of 2 years
Secondary outcomes:
measure: Size of white spot lesion (WSL)
timeFrame: Through to study completion, an average of 2 years
measure: Extent of white spot lesion (WSL)
timeFrame: Through to study completion, an average of 2 years
measure: Participants' perception of WSL
timeFrame: Through to study completion, an average of 2 years
measure: Parents' perception of WSL
timeFrame: Through to study completion, an average of 2 years
measure: MIQ Score
timeFrame: Through to study completion, an average of 2 years
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
state: Merseyside
Study officials:
affiliation: Liverpool University Hospitals NHS Foundation Trust
name: Heather Rogers
role: STUDY_CHAIR
References: