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The main objective of this study is to evaluate if the use of a desensitizing agent (UltraEZ) during in-office bleaching treatment is effective in reducing tooth sensitivity , as well as doesn't affect the degree of tooth bleaching.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UltraEZ Group | Experimental | A blinded clinician put in the patient bleaching trays the UltraEZ desensitizing gel, patients had to wear it 30 minutes before the session of in-office bleaching |
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| Placebo Group | Placebo Comparator | A blinded clinician put in the patient bleaching trays the placebo desensitizing gel, patients had to wear it 30 minutes before the session of in-office bleaching |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UltraEZ | Drug | General Examination with bite-wings, dental prophylaxis, alginate impressions of both arches, creation of individualized bleaching trays and position finder trays. Application of the UltraEZ in the bleaching trays for 30 minutes. Isolation of the gingival tissues. Two applications of the bleaching agent of 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Questionary of dental sensitivity | General tooth sensitivity was assessed using a 5-point Numeric Rating Scale (NRS), where 0 = no sensitivity; 1 = mild discomfort; 2 = moderate discomfort that does not interfere with daily activities; 3 = considerable discomfort leading to avoidance of certain foods and beverages; and 4 = severe sensitivity requiring interruption of the bleaching treatment. Participants selected the numeric value that best represented their perceived level of tooth sensitivity. Pain intensity was recorded at the following time points:
| Perioperative, 1 hour postoperative, 24 hours postoperative, 48 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Color evaluation of each patient | Tooth color will be measured using a dental spectrophotometer, recording the following parameters: L (lightness, representing the shade from black to white on a scale of 0 to 100), a (color variation along the red-green axis, with positive values toward red/purple and negative values toward green/blue), b (color variation along the yellow-blue axis, with positive values toward yellow and negative values toward blue/purple), C (chroma, describing the intensity or saturation of a color, expressed on a scale from 0 to 40, where 0 indicates no saturation and 40 the maximum saturation), and hº (hue, representing the dominant wavelength of a color on a continuous circular scale from 0° to 360°). Color changes between visits will be calculated using the CIELab, CIEDE2000, and White Index for Dentistry (WID) formulas. Color measurements will be recorded at the following time points:
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Medicine and Dentistry | Santiago de Compostela | A Coruña | 15705 | Spain |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C489164 | UltraEZ |
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Randomized, Triple-Blind, Clinical Trial
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| Placebo | Drug | General Examination with bite-wings, dental prophylaxis, alginate impressions of both arches, creation of individualized bleaching trays and position finder trays. Application of the placebo in the bleaching trays for 30 minutes. Isolation of the gingival tissues. Two applications of the bleaching agent of 20 minutes |
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| Baseline (Bleaching Day 1), 1 week later baseline (Before Bleaching day 2), Revision (One week after second bleaching session) |