NCT01733888

Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains

Evaluating the Effect of Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Non Pitted Fluorosis Stains in Indian Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: DMG Dental Material Gesellschaft mbH · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride during the tooth development. The present study is planned to evaluate the efficacy of Resin Infiltration technique in improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin infiltration is a novel method that has shown its efficacy in improving the esthetics of various types of white spot lesions (WSLs), particularly post orthodontics WSLs, in in-situ and in-vivo studies. The Resin Infiltration technique is also known to stop the progression of caries in non cavitated lesions in both, smooth surface and interproximal lesions. Therefore, the following trial will be conducted to assess the esthetic improvement of fluorosed permanent anterior teeth after resin infiltration and compare it with standard bleaching procedure and a combination of bleaching and Resin infiltration therapy in children with fluorosed teeth.

Conditions

• Caries Infiltration
• Fluorosis
• Dental Care

Interventions

Type	Name	Description
DEVICE	Office Bleaching	Teeth will be cleaned with pumice first, followed by placing cheek retractors and covering of the lip surface with petroleum gel. Thereafter, teeth will be dried and gingival barrier will be applied to both arches - slightly overlapping enamel and interproximal spaces. Light curing of the gingival barrier will be done in a fanning motion for 10-20 seconds. This is followed by homogeneous mixing of the powder and liquid in a powder pot the application of a thick layer of the resulting gel to all teeth undergoing treatment (35 % Hydrogen Peroxide, Pola Office, SDI, Australia). The gel will be left in place for 8 minutes and subsequently removed using a surgical aspirator tip.
DEVICE	Resin Infiltration	Fluorosed teeth will be isolated using a rubber dam and the resin infiltrant (Icon, DMG, Hamburg, Germany) will be applied as per manufactures' instructions. In short, tooth surface will be dried using cotton rolls and air syringe. This is followed by an etching (Icon Etch) and drying step (Icon-Dry) to open the lesion surface. Resin infiltrant will then be applied and allowed to seep in for 3 minutes followed by light curing for 40 seconds and subsequent cleaning of the surface with pumice and rubber polishing cup as well as rinsing with water for 30 sec.
DEVICE	Resin Infiltration twice	The intervention will be done similar to the "Resin infiltration" arm, which the exception that the icon infiltration step will be done twice.
DEVICE	Bleaching + Resin Infiltration	In this arm, the fluorosed teeth of the patients will first be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) as explained in the intervention arm "Office bleaching"; followed by wash over period of 20 days. After these 20 days, patients will be recalled and the fluorosed teeth will treated according to the description in the "Resin infiltrant" intervention arm using the resin infiltrant (Icon, DMG, Hamburg, Germany) as per manufactures' instructions.

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-12-01
• Completion: 2014-05-01
• First posted: 2012-11-27
• Last updated: 2022-05-25
• Results posted: 2022-05-25

Locations

2 sites across 1 country: India