Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04855279 |
| Other study ID # |
KN453 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 7, 2019 |
| Est. completion date |
July 26, 2019 |
Study information
| Verified date |
April 2021 |
| Source |
Medipol University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to evaluate the use of different desensitizing agents before in-office
bleaching. A total of 64 volunteers were randomly divided into four groups. Before undergoing
in-office bleaching with 38% hydrogen peroxide gel (three applications of 15 minutes each,
one session), clinicians applied a placebo gel (control group), casein
phosphopeptide-amorphous calcium phosphate (CPP-ACP), neutral sodium fluoride gel (NSF), or
nano-hydroxyapatite solution (n-HAP) on all buccal surfaces of teeth. The gel was left
undisturbed for 4 minutes. Patients recorded their tooth sensitivities on the VAS scale.
Kruskal-Wallis test followed by Mann-Whitney U test were used to compare changes in tooth
color and intensity of tooth sensitivity between groups.
Description:
Color evaluation was performed with Vita Shade Guide Classical (Vitapan Classical, Vita, Bad
Sakingen, Germany). The shades were evaluated with shade guide units (SGUs). Vita Classical
Shade Guide consisted of 16 shades, and the shades were aligned light-to-dark from B1-C4.21,
22 The shades were taken before and after 24 hours and 7 days of treatment.Next, the
hypersensitivity was recorded by asking each subject to establish his or her perception of
sensitivity before treatment using a visual analog scale (VAS). A stimulus of an evaporative
blowing triple syringe (25 psi at ambient conditions) was applied for 3 seconds on the upper
central incisors from a distance of 1 cm. After 24 hours and 7 days of bleaching treatment,
stimuli testing was performed again.The subjects were divided into four groups. Group 1.
Subjects were treated with a placebo gel. The agent was applied for 4 min. to all the teeth
to be bleached. Group 2. Subjects were treated with ACP-CCP gel (Tooth Mousse, GC Corp.,
Tokyo, Japan) for 4 min. to all the teeth to be bleached. Group 3. Subjects were treated with
nano-hydroxyapatite solution for 4 min. to all the teeth to be bleached. Group 4. Subjects
were treated with neutral sodium fluoride (NSF) gel for 4 min. to all the teeth to be
bleached. After treatment, the agent was removed by washing with water in all groups. Each
subject underwent one session of bleaching on the anterior teeth from canine-to-canine.
Bleaching systems were applied according to the manufacturer's instructions by one of the
authors. Subjects were treated with hydrogen peroxide at 38% activated by a light source
composed of 12 LEDs with blue light generators. The calculated hypersensitivity values and
color change values were tested with Shapiro-Wilk and Levene tests for normal data
distribution and homogeneity of variances. Kruskal-Wallis test followed by Mann-Whitney U
test was performed to compare groups.
