Comparison of Two Different Rotary Instruments (RaCe, ProTaper) on Postoperative Pain in Teeth with Asymptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Comparison of two different rotary instruments (RaCe, ProTaper) on postoperative pain in teeth with asymptomatic irreversible pulpitis: A Randomized Clinical Trial
Inclusion criteria: Teeth with asymptomatic irreversible pulpitis; normal radiographic periapical appearance.
Exclusion criteria: Subjects under 20 years of age and over 50 years of age; any systemic diseases; nursing and pregnant women; allergies to lidocaine; reversible pulpitis; symptomatic irreversible pulpitis; pulpal necrosis; PDL widening; periapical radiolucency; teeth with fixed partial dentures; use of any analgesics for at least 12 hours before enrollment in the study.
A total of 78 patients (male or female) 20-50 years of age with a first or second mandibular molar with asymptomatic irreversible pulpitis will enrolled in the study.
Patients will undergo treatment randomly by choosing a packet in which the type of the instrument is written as follows A: ProTaper and B: RaCe groups (39 patients in each group).
After initial working length record, in each group the instruments will be used to prepare canals in a manner according to the manufacturer instructions. The patients will be asked to mark their pain using visual analogue scale at 4-, 12-, 24-, 48- and 72-hour and 1-week postoperative intervals. Finally data will be analyzed. The patients will be blinded to the types of the instruments used (single blind).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503035141N3
Registration date:2015-06-13, 1394/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-13, 1394/03/23
Registrant information
Name
Shahriar Shahi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133559659
Email address
shahis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-06-10, 1394/03/20
Expected recruitment end date
2015-07-29, 1394/05/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Two Different Rotary Instruments (RaCe, ProTaper) on Postoperative Pain in Teeth with Asymptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Public title
Pain Measurement after Root Canal Treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Subjects 20-50 years of age; no systemic diseases; teeth with asymptomatic irreversible pulpitis; normal radiographic periapical appearance.
Exclusion criteria: Subjects under 20 years of age and over 50 years of age; any systemic diseases; nursing and pregnant women; allergies to lidocaine; reversible pulpitis; symptomatic irreversible pulpitis; pulpal necrosis; PDL widening; periapical radiolucency; presence of internal or external resorption; teeth with fixed partial dentures; no bleeding after pulp exposure; use of any analgesics for at least 12 hours before enrollment in the study.
Age
From 74 years old to 43 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Since the patients will be blinded to the types of the instruments used, this study was considered a single-blind one. Patients will undergo treatment randomly by choosing a packet in which the type of the instrument is written (there will be 78 packets).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Floor3- Centeral Building No2-Tabriz University of Medical Sciences- Golgasht St
City
Tabriz
Postal code
Approval date
2015-04-27, 1394/02/07
Ethics committee reference number
TBZMED.REC.1394.47
Health conditions studied
1
Description of health condition studied
Asymptomatic Irreversible Pulpitis
ICD-10 code
K04.0
ICD-10 code description
Irreversible Pulpitis
Primary outcomes
1
Description
Intensity Postoperative Pain after Root Canal Treatment
Timepoint
at 4-, 12-, 24-, 48- and 72-hour and 1-week after root canal treatment
Method of measurement
Visual Analogue Scale(VAS)
Secondary outcomes
1
Description
The Number of Analgesic Tablets Taken
Timepoint
at 4-, 12-, 24-, 48- and 72-hour and 1-week after root canal treatment
Method of measurement
Record by patient
Intervention groups
1
Description
ProTaper rotary instruments (Dentsply-Maillefer, Ballaigues, Switzerland) will be used for the root canal treatment procedures with the crown-down technique based on manufacturer's instructions. Each file will be used to prepare only 8 root canals. The root canals will be obturated with gutta-percha and AH26 sealer (Dentsply,De Trey,Konstanz,Germany).
Category
Other
2
Description
RaCe rotary instruments (FKG Dentaire, Switzerland) will be used for the root canal treatment procedures with the crown-down technique based on manufacturer's instructions. Each file will be used to prepare only 8 root canals. Root canals will be obturated with gutta-percha and AH26 sealer(Dentsply,De Trey,Konstanz,Germany).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontic department-Faculty of Dentistry-Tabriz University of Medical Sciences
Full name of responsible person
Asghari Kalejahi Vahideh
Street address
Endodontic department-Faculty of Dentistry- Tabriz University of Medical Sciences-Golgasht St
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Rashidi Mohammad Reza
Street address
Floor3-Central buildingNo2-Tabriz University of Medical Sciences -Golgasht St
City
Tabriz
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, Tabriz 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
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Rashidi Mohammad Reza
Position
Ph.D./Professor
Other areas of specialty/work
Street address
Floor3-Central building No2-Tabriz University of Medical Sciences -Golgasht St
City
Tabriz
Postal code
Phone
+98 41 3335 7311
Fax
+98 41 3334 4280
Email
rashidi@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shahi Shahriar
Position
Endodontist/Professor
Other areas of specialty/work
Street address
Endodontic Department- Faculty of Dentistry-Tabriz University of Medical Sciences- Golgasht St
City
Tabriz
Postal code
Phone
+98 413335596569
Fax
Email
SShahriar32@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Asghari Kalejahi Vahideh
Position
Post Graduate Student of Endodontic Department
Other areas of specialty/work
Street address
Endodontic Department- Faculty of Dentistry-Tabriz University of Medical Sciences- Golgasht St
City
Tabriz
Postal code
Phone
+98 41 3441 6556
Fax
Email
asghari.v@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)