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

NCT01733888 | Completed Results

• 1 other identifier: FLUORIC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Caries Infiltration; Fluorosis; Dental Care

Keywords

caries; caries infiltration; fluorosis treatment

Outcome Measures

Primary Outcomes (1)

• 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".

  Immediate

Secondary Outcomes (1)

• Improvement in Brown Stains/ Change in White Opacities

  Immediate

Study Arms (4)

Office Bleaching

ACTIVE COMPARATOR

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

Device: Office Bleaching

Resin Infiltration

EXPERIMENTAL

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

Device: Resin Infiltration

Resin Infiltration twice

EXPERIMENTAL

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

Office Bleaching + Resin Infiltration

EXPERIMENTAL

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

Interventions

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.

Also known as: 35 % Hydrogen Peroxide, Pola Office, SDI, Australia

Office Bleaching

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.

Also known as: Icon, Kit for caries infiltration, DMG, Hamburg, Germany

Resin Infiltration

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.

Also known as: Icon Kit for caries infiltration, DMG, Hamburg, Germany

Resin Infiltration twice

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.

Also known as: Icon Kit for Caries Infiltration, DMG, Hamburg, Germany, 35 % Hydrogen Peroxide, Pola Office, SDI, Australia

Office Bleaching + Resin Infiltration

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DMG Dental Material Gesellschaft mbH: lead

Study Sites (2)

Department of Pediatric and Preventive Dentistry DAV Dental College

Yamuna Nagar, Haryana, 135001, India

Location

Department of Pediatric and Preventive Dentistry DRIDS Dental College

Farīdkot, Punjab, India

Location

Related Publications (1)

• 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.

  PMID: 28654721 RESULT

MeSH Terms

Conditions

Fluoride Poisoning

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders

Results Point of Contact

• Title: Manager Clinical Research
• Organization: DMG Dental Material Gesellschaft

clinicalresearch@mtcompanies.com

+494084006

Study Officials

• Neeraj Gugunani, Prof. Dr.

  Department of Pediatric and Preventive Dentistry DAV Dental College Yamuna Nagar 135001 Haryana India

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 27, 2012
• Study Start: July 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: May 25, 2022
• Results First Posted: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)