Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02718183 |
| Other study ID # |
03/16 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
March 16, 2016 |
| Last updated |
March 23, 2016 |
| Start date |
March 2015 |
| Est. completion date |
February 2016 |
Study information
| Verified date |
March 2016 |
| Source |
University of Chile |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Chile: Comité de Ética Científico |
| Study type |
Interventional
|
Clinical Trial Summary
OBJECTIVES: The aim of this clinical randomized, double-blind clinical study was to assess
the markers levels of RANKL IL-1B and OPGL, involved in the external cervical resorption as
a primary outcome, and change color effectiveness in patients undergoing intracoronary
bleaching.
METHOD: 46 volunteers (50 teeth) participated with discoloration on non-vital teeth, with
the endodontic treatment in good condition. Patients were randomly located into two study
groups according to product G1 = 35% hydrogen peroxide (n = 25) and G2 = 37% carbamide
peroxide (n = 25).
The intracameral bleaching was performed with a walking bleaching technique of 4 sessions
Gingivocrevicular transudate samples were taken to determine levels of Il1b, RANKL, and OPGL
with absorbent paper (Periopaper®), they are obtained from six sites per tooth bleaching: 3
vestibular and three palatine (mesial, middle and distal), in 6 opportunities:
Baseline, after 4-sessions of intracameral bleaching and a one week after treatment. Total
proteins are quantified by Bradford ® system and from the eluted sample of RANKL, IL 1b and
OPGL levels measured by ELISA (Quantikine®; R&D Systems Inc.).
The color was evaluated in each session with Vita EasyShade spectrophotometer is used with
the CIEL*a*b system to measure the total variation in color (ΔE), between the baseline and
the different evaluation times.
Description:
The trial was randomized and double-blind (patient and operator). Advertising was held to
invite participation in dental school and through social networks like Facebook or Twitter.
Sample size
To determine the size of the sample GPower 3.1 software was used, considering a significance
level of 5% statistical power of 80%.
A total of 74 patients were examined to assess whether they met the criteria for inclusion
and exclusion. Patients: over 18 years, with one or more non-vital teeth, the restoration
does not cover the vestibular face, endodontic treatment is in good condition, without
apical lesion, with no previous experience of tooth whitening and tooth shade A2 or greater
according to the Vita Classical scale. Patients were excluded pregnant or lactating,
patients with enamel hypoplasia, with teeth stained by tetracycline or fluorosis, in
orthodontic treatment with fixed appliances, patients with cancer or periodontal diseases.
In addition to those volunteers to be examined clinically and radiographically present
caries, periapical lesions, external or internal dental resorption and / or periodontal
disease, as may be informed and referred to specialists for treatment.
46 patients, of whom 44 completed treatment and attended all controls were selected.
Were formed at randomization two study groups as the bleaching agent used, each with teeth n
= 25, G1 = teeth bleached with Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA). G2
= bleached teeth with carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil).
Bleaching procedure
The application of the bleaching agents was performed according to manufacturers
instructions in four sessions with an outpatient technique (Walking Bleaching), with one
week apart from each.
Session Preparation: Preparing root canal with absolute isolation, were removed from 3mm
seal the endodontic cement-enamel limit reference. The final sealing was made with 2mm with
glass ionomer resin composite modificao and curing by (Riva Light Cure, SDI, Australia) and
light-cured for 40 seconds (Cal Radii, SDI, Australia).
Unblocking a radiographic control and sealing the root canal, and radiographs, post seal was
obtained.
4 sessions of Whitening: The Application of the bleaching agent was according to
manufacturer's instructions. An amount of gel bleaching agent was left intracamerally with
moisture (Walking Bleaching). Subsequently he sealed with a temporary cement to the next
session.
Closing session: the access cavity was washed with water and a temporary sealing leave for 7
days prior to the completion of the final seal.
Patients were advised not to eat or drink foods that can stain, such as coffee, tea, red
wine, etc. during the study period. They were given written instructions and contact
information for any questions or problems arise.
Color Evaluation
Two calibrated evaluators, with 80% agreement (Kappa test), recorded the color of teeth at
baseline (baseline), immediately after each bleaching session, one week and one month
post-treatment.
Color evaluation was measured in the middle third of the labial surface of tooth bleaching.
Patients were examined in the same room with the same lighting, for both examiners
independently. using the Vita Bleachguide scale (Vita Zahnfabrik, Bad Säckingen, Germany)
.For every "value" color is assigned a numerical value in order to calculate the change in
units scale (SGU Δ).
Evaluation of markers RANKL-OPG-Interleukin in crevicular gingival fluid (FGC) Obtaining and
handling of samples FGC
FGC samples were obtained from six sites periodontal 3 vestibular and 3 palatal / lingual
(average mesial - distal) undergoing teeth whitening. Samples were taken before the
whitening (baseline) and after each whitening session, a week and a month post-whitening.
For this were used Periopaper® absorbent paper strips (OraFlow Inc., New York, NY, USA). The
teeth were isolated from a relative fashion using cotton rolls, once isolated with a Gracey
3/4 the supra-gingival plaque be removed and gently the surface of the triple air dry
syringe. The paper strip was introduced into the selected tooth gingival sulcus until mild
resistance tissue and held for 30 seconds. Then they were placed in properly labeled
Eppendorf tubes and transported immediately to be stored at -80 ° C until the centrifugal
elution process. The paper strips contaminated with saliva or blood were discarded.
The paper strips were subjected to centrifugal elution to obtain total proteins present in
the FGC. To do this, incubated for 30 minutes in 100 .mu.l of elution buffer containing
0.05% Tween in Tris-HCl pH 7.4 (Fluka, Sigma-Aldrich Chemie GmbH, Buchs, Switzerland) and
then centrifugarnn 10,000 xg for 5 minutes at 4 ° C. The process of centrifugal
circumvention repetio 3 times to a final volume of 300 ul, which was stored at -80 ° C until
analysis.
Evaluation of markers RANKL-OPG-Interleukin in crevicular gingival fluid (FGC) Total
proteins were quantified by the Bradford ® system (R & D Systems Inc., Minneapolis, MN, USA)
and from 50 ul of sample eluted from medieronn levels of RANKL, OPG and interleukin by ELISA
(Quantikine®; R & D Systems Inc. ) following the manufacturer's protocol. The average
absorbance at 492 nm with correction at 630 nm using an automated plate reader (Universal
ELx800 Microplate Reader, Bio-Tek Instruments Inc., Winooski, VT, USA). The concentration of
the markers in each sample was calculated using an equation of the line of 4th grade.
