Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04793477 |
| Other study ID # |
UIC-ODP-LIMAS |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
July 1, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Universitat Internacional de Catalunya |
| Contact |
Francisco Guinot Jimeno, DDS, MsC |
| Phone |
935042000 |
| Email |
fguinot[@]uic.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Is an in vivo study to test the effectiveness of the reciprocating system Reciproc blue and
the rotating system VDW.ROTATE in primary molars.
Description:
It is a randomized controlled clinical study to be conducted in the Department of Pediatric
Dentistry of the International University of Catalonia (UIC).
The clinical study and data collection will be obtained by the second year students of the
master's degree in Pediatric Dentistry. All of them will receive the same practical and
theoretical training on the treatment to be performed, and will be calibrated by the
principal investigator. The procedure and the data obtained will be reviewed by a trained
investigator and blinded with the type of procedure used.
Children from 4 to 8 years old will be selected to visit the Clinica Universitaria de
Odontología (CUO) with the master's degree in Pediatric Dentistry. A sample of 60 children
will be taken. There will be three study groups, where 20 subjects will be assigned to each,
estimating a follow-up loss ratio of 20%.
Once the patient is selected, they will be assigned to one of the groups in order of arrival.
For example, patient one will be assigned in group 1, patient two in group 2, patient three
in group 3 and so on.
There are 3 study groups groups: Group 1, with Manual instrumentation with K files (Dentsply
Caulk, Milfors, DE, USA); group 2, with the VDW.ROTATETM (VDW, Munich, Germany); and group 3,
with Reciproc® Blue (RCP, VDW, Munich, Germany) system.
A preliminary clinical and radiographic examination with periapical radiographs will be
performed. To anesthetize the tooth, the student will use topical anesthesia (Urricaine gel,
Clarben SA Laboratories) and local anesthesia with articaine 4% 1:200,000 epinephrine
(Ultracaine; Normon S.A., Madrid, Spain) using a lower alveolar nerve block. The student will
work with absolute isolation with rubber dam. The cavities will be removed with a high-speed
diamond ball cutter and once the operator are inside the pulp chamber, will continue to
remove the coronal pulp with a endo-Z cutter.
The operator will determine the working length (LT) with the Gold Reciproc motor (VDW,
Munich, Germany), using K #15 file. LT is to be determined it at 1 mm less than what the
locator indicates due to the physiological reabsorptions present in the tooth. Each group
will be instrumented according to the manufacturer's instructions, explained above. The duct
permeability will be ensured with K #10 file with between files and at the end of the
instrumentation. The duct irrigation was carried out with 5ml of 2,5% NaOCl in each duct and
a side outlet needle. In the case of group 3, which is a single lime system, the operator
will take into account that the irrigation must be similar to that of the other systems.
Once the instrumentation is finished,the elapsed time will be recorded from the beginning to
the end of the instrumentation with the disinfection of the appropriate irrigant. The
operator will record the minutes and seconds evaluated with an analog stopwatch. The ducts
will be dried with sterile paper tips and place the sealing material, calcium hydroxide with
iodophormic paste (Vitapex; Neo Dental International Inc., Federal Way, WA, USA). The sealing
material will be placed with the applicator tip that comes with the product and at the end we
will compact the sealing with a cotton ball in the chamber. The application material
procedure will be carried out in this way, to know if the success of the sealing depends on
the system of files used. The tooth will remain with a temporary Eugenol Zinc Oxide (IRM;
Dentsply Caulk, Milfors, DE, USA) filler until the next visit, which will be a week later, to
place a stainless steel crown (3M ESPE, St. Paul, MN, USA) cemented with glass ionomer cement
(Ktac-Cem;3M ESPE, St. Paul, MN, USA).
To finish the treatment, a periapical radiography will be done to the patient. With the final
periapical radiography, a researcher blinded to the study groups, will evaluate the quality
and quantity of the seal without the need for auxiliary elements such as léntulos or files.
The filling will be evaluated if it's optimal, under-filled, over-filled or with the presence
of gaps.
To determine the patient's anxiety during dental treatment, the operator will use a pulse
oximeter (digital Onyx, NONIN, Plymouth, MN, USA). The child's heart rate will be evaluated
in the following moments: 3 min before the application of topical anesthesia, at the topical
anesthesia aplication, during the application of the local anesthetic, when the rubber dam is
placed, during the instrumentation and removal of coronal pulp tissue, during the
instrumentation with each file system, and finally when the rubber dam is removed. The
average heart rate will be determined for each period by a set of values in a period of 1
minute.
At the end of the treatment the operator will evaluate the behavior of the child with the
Frankl scale where 1 is very uncooperative and 4 is very collaborative; and will see if it is
similar to the behavior of previous visits with conservative treatment.
To determine the ease of operation, a numerical scale from 0 to 10 is will be used, where 0
means very easy to use and 10 very difficult. It will be taken into account that if there are
more than one operator, they have the same acquired skills and the same familiarity with the
file systems used.
In the evaluation of postoperative pain, that same day the patient's parents will be given a
questionnaire where the parents will have to write down at 6, 12, 24, 48, 72 hours and a week
later, the pain felt. The pain will be evaluated with the Wong-Baker scale because facial
scales are usually easier for the pediatric patient. All patients will be given a 2% junifen
prescription with a weight-appropriate dose in case of postoperative pain. Parents will be
advised that the prescription should only be used in cases of more severe pain, and will need
to be noted on the data collection sheet. When these patients need taking medication, the
marked value at the Wong-Baker station will not be taken into account. It will be noted that
they are patients who have required medication. The operator will collect the data a week,
coinciding with the stainless steel crown placement.
All the data obtained from the patients participating in the study will be recorded in two
sheets: One for the operator, where the age, sex, the assigned study group, and all the
variables studied will be recorded: instrumentation time, filler quality, operator's ease,
behavior and anxiety of the patient; The other sheet will be for parents to record at home
the postoperative pain felt by the child.
Statistical analysis will be caried out with Statgraphics Plus 5.1 version and Microsoft
Excel.
An absolute and relative frequency shall be used in categorical variables to describe the
data. For the numerical variables the mean and standard deviation or median and first and
third quartile will be used, depending on whether the data is parametric or not. To be able
to make comparisons between files, the Chi-square T will be used for categorical variables
and the T-student or Mann Whitney test for numerical variables. The SHAPIRO WILKS contrast
will be used to compare the normality of the data.
For this study, a 95% confidence interval is to be taken into account, taking as
statistically significant reference a p value ≤ 0.05.
