Fluorosis Clinical Trial
Official title:
In Vivo Action of Infiltrating Resin Icon® on Fluorosis - a 12 Month Follow up Trial
Clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis.
Dental fluorosis is an endemic public health concern that develops if infants are subjected to excessive amounts of fluoride during enamel formation. Anatomopathologically, dental fluorosis presents itself as a hypermineralized surface layer and subsurface hypomineralization involving the external third of the thickness of the enamel, which is equivalent to early carious lesions. In addition, fluorosis features a number of clinical changes in the enamel surface, ranging from the appearance of thin white lines up to severe structural defects, thereby compromising overall esthetics, which sometimes leads to children dropping out of school due to its psychological impact. The aim of this controlled clinical trial is to evaluate the efficacy of enamel microabrasion and resin infiltration in improving the dental esthetic of patients with fluorosis. Resin infiltration is a microinvasive technique that can improve the esthetics by infiltrating a low-viscosity resin (that has a similar refractive index to enamel) into the porose hypomineralized enamel of fluorosed white spots. This approach thus largely preserves the enamel compared to more invasive techniques such as microabrasion and has been shown to be efficient in previous studies. This study will be conducted in the provinces of Pichincha and Cotopaxi, Ecuador and patients between 10 to 12 years of age with stage 1, 2, and 3 fluorosis according to the Thylstrup and Fejerskov (TF) scale or questionable, very mild, and mild fluorosis according to Dean's Index will be recruited. In addition to the immediate esthetic improvement, long term stability of the outcome will be assessed at 3, 6 and 12 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02958891 -
Dental Health Epidemiology Among Israel Defense Forces (IDF) Recruits
|
N/A | |
| Completed |
NCT01733888 -
Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains
|
N/A |