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

Dental Care Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733888
• Other study ID #: FLUORIC
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2022
• Source: DMG Dental Material Gesellschaft mbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries Infiltration
• Dental Care
• Fluoride Poisoning
• Fluorosis
• Fluorosis, Dental

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
India	Department of Pediatric and Preventive Dentistry DRIDS Dental College	Faridkot	Punjab
India	Department of Pediatric and Preventive Dentistry DAV Dental College	Yamuna Nagar	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
DMG Dental Material Gesellschaft mbH

Country where clinical trial is conducted

India, 

References & 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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".	Immediate