Trial Outcomes & Findings for Combined Bleaching Technique: Efficacy and Tooth Sensitivity (NCT NCT03089216)
NCT ID: NCT03089216
Last Updated: 2019-08-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
108 participants
Primary outcome timeframe
during bleaching, and up to 48 hours postbleaching
Results posted on
2019-08-05
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Combined Bleaching(2x20)
n=27 Participants
two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
|
Combined Bleaching(1x20)
n=27 Participants
two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
|
Combined Bleaching(1x20) With Arginine
n=27 Participants
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.
|
Combined Bleaching(2x20) With Arginine
n=27 Participants
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.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=108 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
108 Participants
n=108 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=108 Participants
|
|
Age, Continuous
|
20.8 years
STANDARD_DEVIATION 2.1 • n=27 Participants
|
22.7 years
STANDARD_DEVIATION 3.1 • n=27 Participants
|
20.7 years
STANDARD_DEVIATION 2.1 • n=27 Participants
|
20.8 years
STANDARD_DEVIATION 1.7 • n=27 Participants
|
21.2 years
STANDARD_DEVIATION 2.1 • n=108 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=27 Participants
|
14 Participants
n=27 Participants
|
17 Participants
n=27 Participants
|
21 Participants
n=27 Participants
|
69 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=27 Participants
|
13 Participants
n=27 Participants
|
10 Participants
n=27 Participants
|
6 Participants
n=27 Participants
|
39 Participants
n=108 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: during bleaching, and up to 48 hours postbleachingTooth 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.
Outcome measures
| Measure |
Combined Bleaching(2x20)
n=27 Participants
two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
|
Combined Bleaching(1x20)
n=27 Participants
two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
|
Combined Bleaching(1x20) With Arginine
n=27 Participants
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.
|
Combined Bleaching(2x20) With Arginine
n=27 Participants
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.
|
|---|---|---|---|---|
|
Tooth Sensitivity (TS)
Intensity of TS during bleaching (NRS scale)
|
1 score on a scale
Interval 0.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Tooth Sensitivity (TS)
Intensity of TS up to 48 hours (NRS scale)
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Tooth Sensitivity (TS)
Intensity of TS during bleaching (VAS scale)
|
0.8 score on a scale
Interval 0.0 to 8.0
|
0.9 score on a scale
Interval 0.0 to 4.0
|
0.6 score on a scale
Interval 0.0 to 6.0
|
0.3 score on a scale
Interval 0.0 to 8.0
|
|
Tooth Sensitivity (TS)
Intensity of TS up to 48 hours (VAS scale)
|
0 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: The evaluations were performed in the baseline period and one month after the treatmentObjective 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.
Outcome measures
| Measure |
Combined Bleaching(2x20)
n=27 Participants
two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
|
Combined Bleaching(1x20)
n=26 Participants
two 20-minute 35%HP applications (2x20); at-home bleaching was performed with 10% carbamide peroxide (CP) for two hours daily for 16 days.
|
Combined Bleaching(1x20) With Arginine
n=27 Participants
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.
|
Combined Bleaching(2x20) With Arginine
n=26 Participants
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.
|
|---|---|---|---|---|
|
Color Evaluation
|
8.28 percentage of color change
Standard Deviation 2.73
|
8.18 percentage of color change
Standard Deviation 2.76
|
7.72 percentage of color change
Standard Deviation 2.61
|
8.11 percentage of color change
Standard Deviation 2.76
|
Adverse Events
Combined Bleaching(2x20)
Serious events: 22 serious events
Other events: 22 other events
Deaths: 0 deaths
Combined Bleaching(2x20) With Arginine
Serious events: 16 serious events
Other events: 16 other events
Deaths: 0 deaths
Combined Bleaching(1x20)
Serious events: 23 serious events
Other events: 23 other events
Deaths: 0 deaths
Combined Bleaching(1x20) With Arginine
Serious events: 16 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combined Bleaching(2x20)
n=27 participants at risk
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.
|
Combined Bleaching(2x20) With Arginine
n=27 participants at risk
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.
|
Combined Bleaching(1x20)
n=27 participants at risk
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.
|
Combined Bleaching(1x20) With Arginine
n=27 participants at risk
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.
|
|---|---|---|---|---|
|
Investigations
Tooth Sensitivity (Score of >3)
|
81.5%
22/27 • Number of events 27 • 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").
|
59.3%
16/27 • Number of events 27 • 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").
|
85.2%
23/27 • Number of events 27 • 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").
|
59.3%
16/27 • Number of events 27 • 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").
|
Other adverse events
| Measure |
Combined Bleaching(2x20)
n=27 participants at risk
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.
|
Combined Bleaching(2x20) With Arginine
n=27 participants at risk
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.
|
Combined Bleaching(1x20)
n=27 participants at risk
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.
|
Combined Bleaching(1x20) With Arginine
n=27 participants at risk
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.
|
|---|---|---|---|---|
|
Investigations
Tooth Sensitivity (Score of <3)
|
81.5%
22/27 • 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").
|
59.3%
16/27 • 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").
|
85.2%
23/27 • 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").
|
66.7%
18/27 • 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").
|
Additional Information
Dr. Terezinha de Jesus Esteves Barata
Federal University of Goias
Phone: +55 62 3209-6325
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place