Clinical trial
A Randomised, Controlled Trial to Assess the Effect of Different Modes of Fluoride Delivery on Enamel Demineralisation, During Orthodontic Treatment With Fixed Appliances
Name
5604
Description
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.
Trial arms
Trial start
2023-10-20
Estimated PCD
2025-09-30
Trial end
2025-09-30
Status
Recruiting
Phase
Early phase I
Treatment
Fluoride mouthwash (0.05%; 225ppm).
Mouthwash
Arms:
Mouthwash
Other names:
Fluorigard
Tooth Mousse Plus
Tooth Mousse
Arms:
Tooth Mousse
Other names:
Recaldent™ CPP-ACP [casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP)] and Sodium Fluoride 0.2% w/w (900 ppm).
Size
130
Primary endpoint
New white spot lesions (WSLs)
Through to study completion, an average of 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}
Updated at
2023-11-08
1 organization
2 products
2 indications
Product
Fluoride mouthwashIndication
Orthodontic Appliance ComplicationIndication
Dental CariesProduct
Tooth Mousse Plus