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NCT Number: NCT01733888

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

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.

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Key information

Conditions

Caries Infiltration Chemically-Induced Disorders Dental Care Fluoride Poisoning Fluorosis Poisoning

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric and Preventive Dentistry DAV Dental College, Yamuna Nagar, Haryana, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Office Bleaching

Device

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.

Other names: 35 % Hydrogen Peroxide, Pola Office, SDI, Australia

Resin infiltration

Device

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.

Other names: Icon, Kit for caries infiltration, DMG, Hamburg, Germany

Resin Infiltration twice

Device

The intervention will be done similar to the "Resin infiltration" arm, which the exception that the icon infiltration step will be done twice.

Other names: Icon Kit for caries infiltration, DMG, Hamburg, Germany

Bleaching + Resin Infiltration

Device

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.

Other names: Icon Kit for Caries Infiltration, DMG, Hamburg, Germany, 35 % Hydrogen Peroxide, Pola Office, SDI, Australia

Primary outcomes

  1. Esthetic Changes

    Time frame: Immediate

    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 outcomes

  1. Improvement in Brown Stains/ Change in White Opacities

    Time frame: Immediate

    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".

Sponsors and collaborators

Lead sponsor

DMG Dental Material Gesellschaft mbH

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 27, 2012
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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