Fluoride Delivery to Prevent White Spots During Orthodontic Treatment

NCT05005689 | Unknown Phase 4 DMC

• 1 other identifier: 5604
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Appliance Complication; Tooth Demineralization

Keywords

Fluoride; CPP-ACP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Size of white spot lesion (WSL)

  Through to study completion, an average of 2 years

• Extent of white spot lesion (WSL)

  Through to study completion, an average of 2 years

• Participants' perception of WSL

  Through to study completion, an average of 2 years

• Parents' perception of WSL

  Through to study completion, an average of 2 years

• MIQ Score

  Through to study completion, an average of 2 years

Study Arms (2)

Mouthwash

ACTIVE COMPARATOR

Fluoride mouthwash (0.05%; 225ppm) 10ml for 1 minute daily

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

Drug: Tooth Mousse Plus

Interventions

Fluoride mouthwash (0.05%; 225ppm). DRUG

Mouthwash

Also known as: Fluorigard

Mouthwash

Tooth Mousse Plus DRUG

Tooth Mousse

Also known as: Recaldent™ CPP-ACP [casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP)] and Sodium Fluoride 0.2% w/w (900 ppm).

Tooth Mousse

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Planned to receive orthodontic treatment with upper and lower fixed orthodontic appliances (braces) either alone or following a period of functional appliance treatment.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Liverpool University Hospitals NHS Foundation Trust

Liverpool, Merseyside, L9 7AL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Tooth Demineralization

Interventions

Sodium Fluoride; casein phosphopeptide-amorphous calcium phosphate nanocomplex

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Heather Rogers

  Liverpool University Hospitals NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Jayne E Harrison, FDS, PhD

CONTACT

441517065030; Jayne.Harrison@liverpoolft.nhs.uk

Norah L Flannigan, FDS, PhD

CONTACT

441517065210; NLF@liverpool.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: August 13, 2021
• Study Start: October 20, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)