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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Office Bleaching | Active Comparator | Fluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. |
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| Resin Infiltration | Experimental | White spots in fluorosed teeth will be infiltrated using the resin infiltrant "Icon" (DMG, Hamburg, Germany) according to manufactures´ instructions. |
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| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neeraj Gugunani, Prof. Dr. | Department of Pediatric and Preventive Dentistry DAV Dental College Yamuna Nagar 135001 Haryana India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatric and Preventive Dentistry DAV Dental College | Yamuna Nagar | Haryana | 135001 | India | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28654721 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | In-office Bleaching | In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. |
| FG001 | Resin Infiltration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
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| 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. |
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| 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. |
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| Department of Pediatric and Preventive Dentistry DRIDS Dental College |
| Farīdkot |
| Punjab |
| India |
Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.
| FG002 | Resin Infiltration Twice | Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant "Icon" is applied twice. |
| FG003 | In-office Bleaching + Resin Infiltration | In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany). |
| COMPLETED |
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| NOT COMPLETED |
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Patients with non-pitted fluorosis were selected from a high fluoride belt.
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| ID | Title | Description |
|---|---|---|
| BG000 | In-office Bleaching | In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. |
| BG001 | Resin Infiltration | Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. |
| BG002 | Resin Infiltration Twice | Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant "Icon" is applied twice. |
| BG003 | In-office Bleaching + Resin Infiltration | In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | Posted | Mean | Standard Deviation | score on a scale | Immediate |
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| 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". | Posted | Mean | Standard Deviation | score on a scale | Immediate |
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6 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In-office Bleaching | In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. | 0 | 20 | 0 | 20 | ||
| EG001 | Resin Infiltration | Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. | 0 | 20 | 0 | 20 | ||
| EG002 | Resin Infiltration Twice | Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant "Icon" is applied twice. | 0 | 20 | 0 | 20 | ||
| EG003 | In-office Bleaching + Resin Infiltration | In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany). | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Clinical Research | DMG Dental Material Gesellschaft | +494084006 | 0 | clinicalresearch@mtcompanies.com |
| ID | Term |
|---|---|
| D005458 | Fluoride Poisoning |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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