Evaluation of dental pulp responsiveness to electric pulp test to 0.014 and 0.012 initial arch-wire NiTi in patients under fixed orthodontic treatment: a randomized clinical trial
Objectives: To evaluate dental pulp responsiveness to electric pulp Test to 0.014 and 0.012 initial arch-wire NiTi in patients under fixed orthodontic treatment.
Design: A randomized clinical trial.
Setting and conduct: The eligible patients under fixed orthodontic treatment who will refer to School of Dentistry during the study period will be enrolled into the trial.
Inclusion criteria: Need to fixed orthodontic treatment; presence of 5 to 9 millimeters space in the anterior portion of arc; age of 10 to 60 years.
Exclusion criteria: Systemic diseases; using drugs; healthy periodontal tissues; closed apex; healthy teeth; a history of orthodontic treatment.
Intervention group 1: Treatment with 0.014 initial arch-wire NiTi.
Intervention group 2: Treatment with 0.012 initial arch-wire NiTi.
Control group: Patients who do need orthodontic treatment.
Primary outcome: Assessing responsiveness to electric pulp test using EPT before intervention, 5 minutes after intervention and one month later.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705279014N165
Registration date:2017-06-01, 1396/03/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-01, 1396/03/11
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-06-03, 1396/03/13
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of dental pulp responsiveness to electric pulp test to 0.014 and 0.012 initial arch-wire NiTi in patients under fixed orthodontic treatment: a randomized clinical trial
Public title
Evaluation of dental pulp responsiveness to electric pulp test to 0.014 and 0.012 initial arch-wire NiTi in patients under fixed orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Need to fixed orthodontic treatment; presence of 5 to 9 millimeters space in the anterior portion of arc; age of 10 to 60 years.
Exclusion criteria: Systemic diseases; using drugs; healthy periodontal tissues; closed apex; healthy teeth; a history of orthodontic treatment.
Age
From 10 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
510
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.UMSHA.REC.1396.132
Health conditions studied
1
Description of health condition studied
Orthodontic treatment
ICD-10 code
Z46.4
ICD-10 code description
Fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Assessing responsiveness to electric pulp test
Timepoint
before intervention, 5 minutes after intervention and one month later
Method of measurement
using EPT
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Treatment with 0.014 initial arch-wire NiTi.
Category
Treatment - Devices
2
Description
Intervention group 2: Treatment with 0.012 initial arch-wire NiTi.
Category
Treatment - Devices
3
Description
Control group: Patients who do need orthodontic treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr Nazanin Shahsavand
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Nazanin Shahsavand
Position
Resident of Endodontics
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
shndnzn@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Zakiyeh Donyavi
Position
Endodontist
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
zakiyeh_donyavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)