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The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching application under two different time protocols, and dentifrice containing arginine 8% and carbonate calcium use. One hundred eight participants who meet the study inclusion criteria will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color. The data collected will be submitted to the factorial statistical analysis for evaluation of color and chi-square test for tooth sensitivity (α = 5%).
This study will be conducted under the CONSORT recommendations. After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal University of Goias located in Goiania. One hundred eight participants 108 volunteers will be selected on the criteria that qualify inclusion and exclusion from the study will be reported all volunteers were examined not qualify under the criteria for inclusion as part of the initial according to CONSORT recommendations .
After signing the signed an informed consent form all volunteer participants will receive a dental prophylaxis with pumice and water in a rubber cups for the removal of extrinsic stains two weeks before the beginning of tooth whitening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Bleaching(2x20) | Experimental | In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide |
|
| Combined Bleaching(2x20) with arginine | Experimental | Combined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate. |
|
| Combined Bleaching(1x20) | Experimental | In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide |
|
| Combined Bleaching(1x20) with arginine | Experimental | Combined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Bleaching(2x20) | Procedure | one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Tooth Sensitivity (TS) | Tooth sensitivity (TS) was evaluated using a five-point rating scale (NRS), in which 0 = none (minimum value), 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe (maximum value); and a visual analogue scale (VAS) in wich each participant placed a line perpendicular to a 10-cm-long line (on which 0 referred to "no pain" (minimum value) and 10 referred to "severe pain" (maximum value)). Tooth sensitivity (TS) was evaluated during bleaching, and up to 48 hours postbleaching. The worst TS score or numeric value obtained in each assessment was considered for statistical purposes. It was calculated an average to obtain the median. | during bleaching, and up to 48 hours postbleaching |
| Measure | Description | Time Frame |
|---|---|---|
| Color Evaluation | Objective color evaluation: The shade was determined using spectrophotometer VITA Easyshade, in which the parameters L*, a*, and b*, in which L* represents the value from 0 (black) to 100 (white) and a* and b* represent the shade, where a* is the measurement along the red-green axis and b* is the measurement along the yellow-blue axis. The color alteration (ΔE) was determined by the differences between the values obtained at baseline and one month after the treatment, which was calculated with the formula: ΔE = [(ΔL *) 2 + (Δa *) 2 + (Δb *) 2]1/2. In the Outcome Measure Data Table it was presented Mean and Standard Deviation of the color alteration (ΔE) between Baseline vs one month after bleaching for each group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabella N Favarão, DDS, MS | Universidade Federal de Goias | Principal Investigator |
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A total of 325 participants were examined to check whether they met the inclusion and exclusion criteria; 217 participants were excluded because they presented initial conditions described in the exclusion criteria of the study; 108 were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Bleaching(2x20) | two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. |
| FG001 | Combined Bleaching(1x20) | two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. |
| FG002 | Combined Bleaching(1x20) With Arginine | one 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment. |
| FG003 | Combined Bleaching(2x20) With Arginine | two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combined Bleaching(2x20) | two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. |
| BG001 | Combined Bleaching(1x20) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Tooth Sensitivity (TS) | Tooth sensitivity (TS) was evaluated using a five-point rating scale (NRS), in which 0 = none (minimum value), 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe (maximum value); and a visual analogue scale (VAS) in wich each participant placed a line perpendicular to a 10-cm-long line (on which 0 referred to "no pain" (minimum value) and 10 referred to "severe pain" (maximum value)). Tooth sensitivity (TS) was evaluated during bleaching, and up to 48 hours postbleaching. The worst TS score or numeric value obtained in each assessment was considered for statistical purposes. It was calculated an average to obtain the median. | Posted | Median | Inter-Quartile Range | score on a scale | during bleaching, and up to 48 hours postbleaching |
|
Tooth sensitivity was evaluated at baseline and up to 48 hours after the combined bleaching.
A five-point rating scale (NRS), in wich 0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe, as well as a visual analogue scale (VAS) was used to performed tooth sensitivity. Each participant placed a line perpendicular to a 10-cm-long line (on which 0 referred to "no pain" and 10 referred to "severe pain").
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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 | Combined Bleaching(2x20) | In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Combined Bleaching(2x20): one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth Sensitivity (Score of >3) | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth Sensitivity (Score of <3) | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terezinha de Jesus Esteves Barata | Federal University of Goias | +55 62 3209-6325 | terezinhabarata@yahoo.com.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2017 | May 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D001120 | Arginine |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Combined Bleaching(2x20) with arginine | Procedure | one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. |
|
| Combined Bleaching (1x20) | Procedure | one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. |
|
| Combined Bleaching(1x20) with arginine | Procedure | one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. |
|
| 8% arginine and calcium carbonate | Drug | using during all the treatment. |
|
|
| The evaluations were performed in the baseline period and one month after the treatment |
two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
| BG002 | Combined Bleaching(1x20) With Arginine | one 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment. |
| BG003 | Combined Bleaching(2x20) With Arginine | two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Combined Bleaching(1x20) | two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. |
| OG002 | Combined Bleaching(1x20) With Arginine | one 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment. |
| OG003 | Combined Bleaching(2x20) With Arginine | two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days. dentifrice containing 8% arginine and calcium carbonate was used during all treatment. |
|
|
| Secondary | Color Evaluation | Objective color evaluation: The shade was determined using spectrophotometer VITA Easyshade, in which the parameters L*, a*, and b*, in which L* represents the value from 0 (black) to 100 (white) and a* and b* represent the shade, where a* is the measurement along the red-green axis and b* is the measurement along the yellow-blue axis. The color alteration (ΔE) was determined by the differences between the values obtained at baseline and one month after the treatment, which was calculated with the formula: ΔE = [(ΔL *) 2 + (Δa *) 2 + (Δb *) 2]1/2. In the Outcome Measure Data Table it was presented Mean and Standard Deviation of the color alteration (ΔE) between Baseline vs one month after bleaching for each group. | Posted | Mean | Standard Deviation | percentage of color change | The evaluations were performed in the baseline period and one month after the treatment |
|
|
|
| 22 |
| 27 |
| 22 |
| 27 |
| EG001 | Combined Bleaching(2x20) With Arginine | Combined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate. Combined Bleaching(2x20) with arginine: one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. 8% arginine and calcium carbonate: using during all the treatment. | 16 | 27 | 16 | 27 |
| EG002 | Combined Bleaching(1x20) | In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Combined Bleaching (1x20): one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. | 23 | 27 | 23 | 27 |
| EG003 | Combined Bleaching(1x20) With Arginine | Combined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate. Combined Bleaching(1x20) with arginine: one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. 8% arginine and calcium carbonate: using during all the treatment. | 16 | 27 | 18 | 27 |
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| D000601 | Amino Acids, Essential |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|