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

Not Applicable
Completed
Conditions
Caries Infiltration
Dental Care
Fluorosis
Interventions
Device: Resin Infiltration twice
Device: Bleaching + Resin Infiltration
Device: Office Bleaching
Device: Resin Infiltration
Registration Number
NCT01733888
Lead Sponsor
DMG Dental Material Gesellschaft mbH
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Resin Infiltration twiceResin Infiltration twiceWhite 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.
Office Bleaching + Resin InfiltrationBleaching + Resin InfiltrationFluorosed 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).
Office BleachingOffice BleachingFluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
Resin InfiltrationResin InfiltrationWhite spots in fluorosed teeth will be infiltrated using the resin infiltrant "Icon" (DMG, Hamburg, Germany) according to manufactures´ instructions.
Primary Outcome Measures
NameTimeMethod
Esthetic ChangesImmediate

Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with "1 = no improvement" and "7 = exceptional improvement".

Secondary Outcome Measures
NameTimeMethod
Improvement in Brown Stains/ Change in White OpacitiesImmediate

Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with "1 = no improvement" and "7 = exceptional improvement".

Trial Locations

Locations (2)

Department of Pediatric and Preventive Dentistry DRIDS Dental College

🇮🇳

Faridkot, Punjab, India

Department of Pediatric and Preventive Dentistry DAV Dental College

🇮🇳

Yamuna Nagar, Haryana, India

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