Trial Outcomes & Findings for Anti-inflammatory Steroids in the Prevention of Tooth Sensitivity (NCT NCT02956070)
NCT ID: NCT02956070
Last Updated: 2020-11-25
Results Overview
The investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
One hour
Results posted on
2020-11-25
Participant Flow
Participant milestones
| Measure |
Experimental
35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention.
Dexamethasone acetate: The volunteers in the Dexamethasone acetate group (experimental group) received six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before session whitening, 8 mg (1 capsule) to 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo gel will be applied w
|
Placebo
35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention
Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch \[50%\], lactose monohydrate \[35%\], dibasic calcium phosphate \[14%\], and magnesium stearate \[1%\]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental
n=35 Participants
35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention.
Dexamethasone acetate: The volunteers in this group received 6 capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg 9 am to 1 day before session whitening, 8 mg 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
|
Placebo
n=35 Participants
35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention
Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch \[50%\], lactose monohydrate \[35%\], dibasic calcium phosphate \[14%\], and magnesium stearate \[1%\]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.3 years
STANDARD_DEVIATION 2.7 • n=35 Participants
|
22.5 years
STANDARD_DEVIATION 2.1 • n=35 Participants
|
22.4 years
STANDARD_DEVIATION 2.4 • n=70 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=35 Participants
|
23 Participants
n=35 Participants
|
50 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=35 Participants
|
12 Participants
n=35 Participants
|
20 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
35 participants
n=35 Participants
|
35 participants
n=35 Participants
|
70 participants
n=70 Participants
|
PRIMARY outcome
Timeframe: One hourThe investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
Outcome measures
| Measure |
Experimental
n=35 Participants
35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention.
Dexamethasone acetate: The volunteers in this group received 6 capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg 9 am to 1 day before session whitening, 8 mg 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
|
Placebo
n=35 Participants
35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention
Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch \[50%\], lactose monohydrate \[35%\], dibasic calcium phosphate \[14%\], and magnesium stearate \[1%\]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
|
|---|---|---|
|
Visual Analogic Scale (0-100) for Tooth Sensibility.
|
6.31 units on a scale
Standard Deviation 12.78
|
11.14 units on a scale
Standard Deviation 20.08
|
PRIMARY outcome
Timeframe: Twenty four hoursThe investigators evaluated the tooth sensibility 24 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
Outcome measures
| Measure |
Experimental
n=35 Participants
35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention.
Dexamethasone acetate: The volunteers in this group received 6 capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg 9 am to 1 day before session whitening, 8 mg 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
|
Placebo
n=35 Participants
35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention
Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch \[50%\], lactose monohydrate \[35%\], dibasic calcium phosphate \[14%\], and magnesium stearate \[1%\]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
|
|---|---|---|
|
Visual Analogic Scale(0-100) for Tooth Sensibility.
|
5.06 units on a scale
Standard Deviation 9.86
|
8.26 units on a scale
Standard Deviation 13.48
|
PRIMARY outcome
Timeframe: Forty eight hoursThe investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility
Outcome measures
| Measure |
Experimental
n=35 Participants
35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention.
Dexamethasone acetate: The volunteers in this group received 6 capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg 9 am to 1 day before session whitening, 8 mg 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
|
Placebo
n=35 Participants
35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention
Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch \[50%\], lactose monohydrate \[35%\], dibasic calcium phosphate \[14%\], and magnesium stearate \[1%\]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
|
|---|---|---|
|
Visual Analogic Scale(0-100) for Tooth Sensibility.
|
0.37 units on a scale
Standard Deviation 1.54
|
2.91 units on a scale
Standard Deviation 9.14
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Luiz Augusto Poubel
Universidade Federal Fluminense
Phone: 55 21 981113344
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place