Caries Infiltration, Dental Care, Fluorosis
Conditions
Keywords
caries, caries infiltration, fluorosis treatment
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.
Interventions
DEVICEOffice 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.
DEVICEResin 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.
DEVICEResin 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.
DEVICEBleaching + 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.
Sponsors
DMG Dental Material Gesellschaft mbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Esthetic Changes | Immediate | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Brown Stains/ Change in White Opacities | Immediate | 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. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| In-office Bleaching In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. | 20 |
| Resin Infiltration Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. | 20 |
| 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. | 20 |
| 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). | 20 |
| Total | 80 |
Baseline characteristics
| Characteristic | In-office Bleaching | Resin Infiltration | Resin Infiltration Twice | In-office Bleaching + Resin Infiltration | Total |
|---|---|---|---|---|---|
| Age, Continuous | 11.3 years STANDARD_DEVIATION 0.5 | 11.1 years STANDARD_DEVIATION 0.9 | 11.6 years STANDARD_DEVIATION 0.5 | 11.1 years STANDARD_DEVIATION 0.8 | 11.3 years STANDARD_DEVIATION 0.7 |
| Race/Ethnicity, Customized Hindu | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized Sikh | 18 Participants | 16 Participants | 18 Participants | 17 Participants | 69 Participants |
| Region of Enrollment India | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants |
| Sex: Female, Male Female | 15 Participants | 9 Participants | 7 Participants | 7 Participants | 38 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 13 Participants | 13 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-office Bleaching | Esthetic Changes | 1.90 score on a scale | Standard Deviation 0.95 |
| Resin Infiltration | Esthetic Changes | 5.50 score on a scale | Standard Deviation 1 |
| Resin Infiltration Twice | Esthetic Changes | 5.53 score on a scale | Standard Deviation 1.97 |
| In-office Bleaching + Resin Infiltration | Esthetic Changes | 5.35 score on a scale | Standard Deviation 1.21 |
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.
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-office Bleaching | Improvement in Brown Stains/ Change in White Opacities | 1.53 score on a scale | Standard Deviation 1.07 |
| Resin Infiltration | Improvement in Brown Stains/ Change in White Opacities | 4.98 score on a scale | Standard Deviation 0.98 |
| Resin Infiltration Twice | Improvement in Brown Stains/ Change in White Opacities | 5.18 score on a scale | Standard Deviation 1.29 |
| In-office Bleaching + Resin Infiltration | Improvement in Brown Stains/ Change in White Opacities | 4.40 score on a scale | Standard Deviation 1.59 |