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This randomized, double-blind clinical trial aimed to evaluate the effect of an experimental gel containing copaiba oil resin in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. The volunteers of this study were randomized into 3 different groups - GC (placebo); GN (potassium nitrate and sodium fluoride); GCO (copaiba oil resin). The dental elements of the GCO received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. The GC and GN groups also received the application of a placebo gel and a nitrate potassium and sodiun fluoride gel, respectively, under the same conditions described for the experimental gel. Subsequently, all groups underwent in-office bleaching treatment with 35% hydrogen peroxide. Post-bleaching sensitivity was collected through a form composed of the visual analogue scale (VAS). Color measurement was performed at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GCO (Experimental copaiba oil resin gel) | Experimental | The GCO group will receive the application of an experimental gel based on copaiba oil resin for post tooth bleaching sensitivity |
|
| GN (Potassiun nitrate and sodium fluoride gel) | Active Comparator | The GN group will receive the application of a potassium and sodium nitrate gel for post tooth bleaching sensitivity |
|
| GC | Placebo Comparator | The GC group will receive the application of a placebo gel for post tooth bleaching sensitivity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GCO (Experimental copaiba oil resin gel) | Other | Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the GCO will receive the application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of post-bleaching sensitivity | For the assessment of postoperative sensitivity, patients were instructed to fill out a form to record tooth sensitivity daily, during the 21 days of treatment, based on individual pain perception. This form was delivered at each bleaching session, being returned to the researcher in the following session, that is, always one week after each bleaching session. The evaluation form consisted of the visual analogue scale (VAS). This scale consists of a 10 cm horizontal line, with scores of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity. The patient was instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity per day. So that the distance in millimeters from the zero end could be later measured with the aid of amillimeter ruler, thus obtaining the patient's level of pain intensity. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Color evaluation | The VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) was used to measure the color, where the area of dental correspondence to be evaluated was the middle third of the buccal surface of the upper canines. To standardize the color readings, silicone trays were made, where the impression was extended from canine to canine. A window was created on the buccal surface of each canine of the silicone guide using a metal device with a 6 mm radius, corresponding to the diameter of the spectrophotometer tip. Thus, the tip of the device was inserted into the silicone guide to obtain the color parameters. Subsequently, the color difference between baseline (T i) and one week after the 3rd bleaching session (T f ) was calculated using the CIEDE2000 formulas (ΔE00). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Para | Belém | Pará | 66075-110 | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 16, 2025 | |
| Reset | Apr 2, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 16, 2025 | Apr 2, 2025 |
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| Baseline (Ti) and one week after the 3rd bleaching session (Tf) |