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

May 24, 2022 updated by: DMG Dental Material Gesellschaft mbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Yamuna Nagar, Haryana, India, 135001
        • Department of Pediatric and Preventive Dentistry DAV Dental College
    • Punjab
      • Faridkot, Punjab, India
        • Department of Pediatric and Preventive Dentistry DRIDS Dental College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Office Bleaching
Fluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
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.
Other Names:
  • 35 % Hydrogen Peroxide, Pola Office, SDI, Australia
Experimental: Resin Infiltration
White spots in fluorosed teeth will be infiltrated using the resin infiltrant "Icon" (DMG, Hamburg, Germany) according to manufactures´ instructions.
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.
Other Names:
  • Icon, Kit for caries infiltration, DMG, Hamburg, Germany
Experimental: Resin Infiltration twice
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.
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.
Other Names:
  • Icon Kit for caries infiltration, DMG, Hamburg, Germany
Experimental: Office Bleaching + Resin Infiltration
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).
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.
Other Names:
  • 35 % Hydrogen Peroxide, Pola Office, SDI, Australia
  • Icon Kit for Caries Infiltration, DMG, Hamburg, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DMG Dental Material Gesellschaft mbH

Investigators

  • Principal Investigator: Neeraj Gugunani, Prof. Dr., Department of Pediatric and Preventive Dentistry DAV Dental College Yamuna Nagar 135001 Haryana India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLUORIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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