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

NCT ID: NCT01733888

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Office Bleaching

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

Group Type: ACTIVE_COMPARATOR

Office Bleaching

Intervention Type: 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.

Resin Infiltration

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

Group Type: EXPERIMENTAL

Resin Infiltration

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Resin Infiltration twice

Intervention Type: DEVICE

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

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).

Group Type: EXPERIMENTAL

Bleaching + Resin Infiltration

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

35 % Hydrogen Peroxide, Pola Office, SDI, Australia; Icon, Kit for caries infiltration, DMG, Hamburg, Germany; Icon Kit for caries infiltration, DMG, Hamburg, Germany; Icon Kit for Caries Infiltration, DMG, Hamburg, Germany; 35 % Hydrogen Peroxide, Pola Office, SDI, Australia

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DMG Dental Material Gesellschaft mbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neeraj Gugunani, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Pediatric and Preventive Dentistry DAV Dental College

Yamuna Nagar, Haryana, India

Department of Pediatric and Preventive Dentistry DRIDS Dental College

Farīdkot, Punjab, India

Countries

India

References

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.

Reference Type: RESULT

PMID: 28654721 (View on PubMed)

Other Identifiers

FLUORIC

Identifier Type: -

Identifier Source: org_study_id