Tooth Bleaching, Tooth Sensitivity
Conditions
Brief summary
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%).
Detailed description
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.
Interventions
PROCEDURECombined 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.
PROCEDURECombined 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.
PROCEDURECombined 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.
PROCEDURECombined 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.
DRUG8% arginine and calcium carbonate
using during all the treatment.
Sponsors
Terezinha de Jesus Esteves Barata
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Upper and lower anterior teeth without restorations; * Upper and lower anterior teeth that have never undergone a bleaching procedure and are A2 or darker in color compared to the Vita Classical).
Exclusion criteria
* Presence of primary and/or secondary carious lesion (s) on upper and lower anterior teeth; * Presence of non-carious lesions, such as abfraction, erosion and abrasion; * Presence of clinically visible cracks or defects of dental enamel on the dental surfaces of the upper and lower anterior teeth; * Use of fixed orthodontic appliances; * Presence of tooth sensitivity classified as equal to or greater than mild; * Presence of severe dental dimming; * Presence of parafunctional habits; * Presence of any oral pathology; * Smokers; * pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tooth Sensitivity (TS) | during bleaching, and up to 48 hours postbleaching | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Color Evaluation | The evaluations were performed in the baseline period and one month after the treatment | 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. |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| 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. | 27 |
| 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. | 27 |
| 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. | 27 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Combined Bleaching(2x20) | Combined Bleaching(1x20) | Combined Bleaching(1x20) With Arginine | Combined Bleaching(2x20) With Arginine | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 27 Participants | 27 Participants | 27 Participants | 108 Participants |
| Age, Continuous | 20.8 years STANDARD_DEVIATION 2.1 | 22.7 years STANDARD_DEVIATION 3.1 | 20.7 years STANDARD_DEVIATION 2.1 | 20.8 years STANDARD_DEVIATION 1.7 | 21.2 years STANDARD_DEVIATION 2.1 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 17 Participants | 21 Participants | 69 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 10 Participants | 6 Participants | 39 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 | 22 / 27 | 16 / 27 | 23 / 27 | 18 / 27 |
| serious Total, serious adverse events | 22 / 27 | 16 / 27 | 23 / 27 | 16 / 27 |
Outcome results
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.
Time frame: during bleaching, and up to 48 hours postbleaching
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Combined Bleaching(2x20) | Tooth Sensitivity (TS) | Intensity of TS during bleaching (NRS scale) | 1 score on a scale |
| Combined Bleaching(2x20) | Tooth Sensitivity (TS) | Intensity of TS up to 48 hours (NRS scale) | 0 score on a scale |
| Combined Bleaching(2x20) | Tooth Sensitivity (TS) | Intensity of TS during bleaching (VAS scale) | 0.8 score on a scale |
| Combined Bleaching(2x20) | Tooth Sensitivity (TS) | Intensity of TS up to 48 hours (VAS scale) | 0 score on a scale |
| Combined Bleaching(1x20) | Tooth Sensitivity (TS) | Intensity of TS up to 48 hours (NRS scale) | 0 score on a scale |
| Combined Bleaching(1x20) | Tooth Sensitivity (TS) | Intensity of TS during bleaching (VAS scale) | 0.9 score on a scale |
| Combined Bleaching(1x20) | Tooth Sensitivity (TS) | Intensity of TS up to 48 hours (VAS scale) | 0 score on a scale |
| Combined Bleaching(1x20) | Tooth Sensitivity (TS) | Intensity of TS during bleaching (NRS scale) | 1 score on a scale |
| Combined Bleaching(1x20) With Arginine | Tooth Sensitivity (TS) | Intensity of TS during bleaching (VAS scale) | 0.6 score on a scale |
| Combined Bleaching(1x20) With Arginine | Tooth Sensitivity (TS) | Intensity of TS up to 48 hours (NRS scale) | 0 score on a scale |
| Combined Bleaching(1x20) With Arginine | Tooth Sensitivity (TS) | Intensity of TS up to 48 hours (VAS scale) | 0 score on a scale |
| Combined Bleaching(1x20) With Arginine | Tooth Sensitivity (TS) | Intensity of TS during bleaching (NRS scale) | 1 score on a scale |
| Combined Bleaching(2x20) With Arginine | Tooth Sensitivity (TS) | Intensity of TS up to 48 hours (VAS scale) | 0 score on a scale |
| Combined Bleaching(2x20) With Arginine | Tooth Sensitivity (TS) | Intensity of TS up to 48 hours (NRS scale) | 0 score on a scale |
| Combined Bleaching(2x20) With Arginine | Tooth Sensitivity (TS) | Intensity of TS during bleaching (NRS scale) | 0 score on a scale |
| Combined Bleaching(2x20) With Arginine | Tooth Sensitivity (TS) | Intensity of TS during bleaching (VAS scale) | 0.3 score on a scale |
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.
Time frame: The evaluations were performed in the baseline period and one month after the treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Bleaching(2x20) | Color Evaluation | 8.28 percentage of color change | Standard Deviation 2.73 |
| Combined Bleaching(1x20) | Color Evaluation | 8.18 percentage of color change | Standard Deviation 2.76 |
| Combined Bleaching(1x20) With Arginine | Color Evaluation | 7.72 percentage of color change | Standard Deviation 2.61 |
| Combined Bleaching(2x20) With Arginine | Color Evaluation | 8.11 percentage of color change | Standard Deviation 2.76 |