NCT02925780

12 Month Follow up in Vivo Icon Study on Fluorotic Teeth

In Vivo Action of Infiltrating Resin Icon® on Fluorosis - a 12 Month Follow up Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: DMG Dental Material Gesellschaft mbH · Industry
• Sex: All
• Age: 10 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis.

Detailed description

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.

Conditions

• Fluorosis
• Oral Deseases

Interventions

Type	Name	Description
DEVICE	Resin infiltration	Teeth selected for this group will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, teeth will be isolated with a rubber dam and the labial tooth surface cleaned with non-fluoride prophylactic paste and pumice. After an etching and drying step (to open the lesion surface), Icon will be applied following the manufacturer's instructions and subsequently light cured, followed by polishing. Digital images are taken before and after the treatment as well as at the follow-up visits (3, 6, 9 and 12 months).
DEVICE	Microabrasion	The labial surfaces of teeth selected for this group will be isolated and precleaned. Subsequently, the microabrasive material, Opalustre, will be applied according to the manufacturer's instructions, using a rubber cup at low speed (5 times each for 5 seconds). Between each of the applications the surface is washed by flushing water using a syringe. Digital images are taken before and after the treatment as well as at the follow-up visits (3, 6, 9 and 12 months).

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-06-01
• Completion: 2021-12-01
• First posted: 2016-10-06
• Last updated: 2023-06-18