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

Primary Purpose

Caries Infiltration, Fluorosis, Dental Care

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Office Bleaching
Resin Infiltration
Resin Infiltration twice
Bleaching + Resin Infiltration
Sponsored by
DMG Dental Material Gesellschaft mbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries Infiltration focused on measuring caries, caries infiltration, fluorosis treatment

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Department of Pediatric and Preventive Dentistry DAV Dental College
  • Department of Pediatric and Preventive Dentistry DRIDS Dental College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Office Bleaching

Resin Infiltration

Resin Infiltration twice

Office Bleaching + Resin Infiltration

Arm Description

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

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

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.

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).

Outcomes

Primary Outcome Measures

Esthetic Changes
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

Improvement in Brown Stains/ Change in White Opacities
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".

Full Information

First Posted
November 14, 2012
Last Updated
May 24, 2022
Sponsor
DMG Dental Material Gesellschaft mbH
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1. Study Identification

Unique Protocol Identification Number
NCT01733888
Brief Title
Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains
Official Title
Evaluating the Effect of Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Non Pitted Fluorosis Stains in Indian Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DMG Dental Material Gesellschaft mbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries Infiltration, Fluorosis, Dental Care
Keywords
caries, caries infiltration, fluorosis treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Office Bleaching
Arm Type
Active Comparator
Arm Description
Fluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
Arm Title
Resin Infiltration
Arm Type
Experimental
Arm Description
White spots in fluorosed teeth will be infiltrated using the resin infiltrant "Icon" (DMG, Hamburg, Germany) according to manufactures´ instructions.
Arm Title
Resin Infiltration twice
Arm Type
Experimental
Arm 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.
Arm Title
Office Bleaching + Resin Infiltration
Arm Type
Experimental
Arm 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).
Intervention Type
Device
Intervention Name(s)
Office Bleaching
Other Intervention Name(s)
35 % Hydrogen Peroxide, Pola Office, SDI, Australia
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Resin Infiltration
Other Intervention Name(s)
Icon, Kit for caries infiltration, DMG, Hamburg, Germany
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Resin Infiltration twice
Other Intervention Name(s)
Icon Kit for caries infiltration, DMG, Hamburg, Germany
Intervention Description
The intervention will be done similar to the "Resin infiltration" arm, which the exception that the icon infiltration step will be done twice.
Intervention Type
Device
Intervention Name(s)
Bleaching + Resin Infiltration
Other Intervention Name(s)
Icon Kit for Caries Infiltration, DMG, Hamburg, Germany, 35 % Hydrogen Peroxide, Pola Office, SDI, Australia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Esthetic Changes
Description
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".
Time Frame
Immediate
Secondary Outcome Measure Information:
Title
Improvement in Brown Stains/ Change in White Opacities
Description
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".
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neeraj Gugunani, Prof. Dr.
Organizational Affiliation
Department of Pediatric and Preventive Dentistry DAV Dental College Yamuna Nagar 135001 Haryana India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric and Preventive Dentistry DAV Dental College
City
Yamuna Nagar
State/Province
Haryana
ZIP/Postal Code
135001
Country
India
Facility Name
Department of Pediatric and Preventive Dentistry DRIDS Dental College
City
Faridkot
State/Province
Punjab
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28654721
Citation
Gugnani N, Pandit IK, Gupta M, Gugnani S, Soni S, Goyal V. Comparative evaluation of esthetic changes in nonpitted fluorosis stains when treated with resin infiltration, in-office bleaching, and combination therapies. J Esthet Restor Dent. 2017 Sep;29(5):317-324. doi: 10.1111/jerd.12312. Epub 2017 Jun 27.
Results Reference
result

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

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