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

Dental Material Gesellschaft

Status: Completed

Conditions: Fluorosis; Caries Infiltration; Dental Care

Treatments: Device: Resin Infiltration twice; Device: Resin Infiltration; Device: Office Bleaching; Device: Bleaching + Resin Infiltration

Study type: Interventional

Funder types: Industry

Identifiers

NCT01733888

FLUORIC

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Only the non-pitted Fluorosis opacities shall be included for this purpose; opacities in anterior teeth shall be classified according to Russell's criteria for differentiating fluoride and non- fluoride opacities
• Subjects classified /Teeth classified with dental fluorosis of 1-4 according to Thylstrup, Fejerskov classification of dental fluorosis 20
• Patients who will be willing to participate in the study and who will be accepting for recall visit.

Exclusion criteria

• History of allergy towards any dental material.
• Teeth classified as non-fluoride opacities
• Subjects with any systemic and local conditions not permitting the treatment
• Subjects who had undergone any treatment for dental fluorosis earlier
• Subjects with direct or indirect restorations in maxillary central or lateral incisors.
• Subjects not willing to participate in the study
• Subjects with fractured teeth maxillary central or lateral incisors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 4 patient groups

Office Bleaching

Active Comparator group

Description:

Fluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.

Treatment:

Device: Office Bleaching

Resin Infiltration

Experimental group

Description:

White spots in fluorosed teeth will be infiltrated using the resin infiltrant "Icon" (DMG, Hamburg, Germany) according to manufactures´ instructions.

Treatment:

Device: Resin Infiltration

Resin Infiltration twice

Experimental group

Description:

White spots in fluorosed teeth will be infiltrated using the resin infiltrant Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. Here, the infiltrant "Icon" is applied twice.

Treatment:

Device: Resin Infiltration twice

Office Bleaching + Resin Infiltration

Experimental group

Description:

Fluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia). After a 20 day wash over period, these teeth will be treated with the resin infiltration intervention (Icon, DMG, Hamburg, Germany).

Treatment:

Device: Bleaching + Resin Infiltration