Clinical Trial: Action of Infiltration Resin Icon in Fluorosis, Clinical Trial, Monitoring for 12 Month

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title:

Brief Summary: Clinical trial to investigate the clinical efficiency of resin infiltration technique for the improvement of dental fluorosis.

Detailed Summary:

Dental fluorosis is an endemic public health concern that affects infants ages 15 to 30 months, being the critical period for an excessive amount of fluoride during enamel formation (Muñoz, Arana-Gordillo, Mongruel, Mongruel, Campanha, et al., 2012). 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 in early carious lesions (Denis, Atlan, Vennat, Tirlet, & Attal, 2013).

In addition, it features a number of clinical changes in the enamel surface, ranging from the appearance of thin white lines up to severe structural defects (Thylstrup, 1978; Aplleton, Chestersa, & Kierdorf, 2000). Up to its mildest forms according to TF and Dean's index, the tip of the summit of the cups of the premolars, molars, or incisal border of the anterior teeth present opacities, faint white flecks, spots, or striations (Muñoz, 2012). Thereby, fluorosis compromises overall esthetics, which sometimes leads to children to drop out of school due to its psychological impact (Denis, et al, 2013). With the aim of improving dental esthetics, a therapeutic alternative such as a minimal invasive infiltrant resin technique, will be used on 31 patients, ages 10 to 12 years of age with stage 1, 2, and 3 of fluorosis according to the Thylstrup and Fejerskov (TF) scale or Questionable, Very Mild, and Mild according to Dean's Index, will be evaluated using digital photography analysis, during 12 months.

The research includes a clinical, longitudinal, and blind study, in which a total of 31 patients: 15 children from the province of Pichincha, Ecuador and an additional 15 from the province of Cotopaxi, Ecuador, are chosen according to inclusion and exclusion criteria upon informed consent of
Sponsor: DMG Dental Material Gesellschaft mbH

Current Primary Outcome: action of DMG Icon-infiltrative ® resin and micro abrasion to mask fluorotic enamel [ Time Frame: immediate after treatment ]

Evaluate the action of DMG Icon-infiltrative resin and micro abrasion immediately after application to mask fluorotic teeth by comparison of pre- vs. post-treatment photographs


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Surface changes [ Time Frame: 12 month ]
    changes that occur on the surface of the teeth with fluorosis, which have been treated with DMG Icon ® and micro-abrasion assessed via photographs
  • Clinical characteristics Icon [ Time Frame: 3, 6, 9, 12 month ]
    clinical characteristics of the tooth surfaces that have been treated with DMG Icon ® and micro-abrasion and its relationship to the degree of fluorosis
  • Efficacy of infiltration to mask fluorotic teeth long-time [ Time Frame: 12 month ]
    Compare the benefit of the infiltrative resin DMG Icon related to micro abrasion Opalustre ULTRADENT as control procedure, focus: stabilisation of masking quantified by photographs


Original Secondary Outcome: Same as current

Information By: DMG Dental Material Gesellschaft mbH

Dates:
Date Received: September 28, 2016
Date Started: December 2016
Date Completion: December 2018
Last Updated: October 4, 2016
Last Verified: September 2016