Comparison of the mean post operative pain after manual and rotary instrumentation for root canal treatment of single rooted teeth with irreversible pulpitis and normal periapex
The present study is aimed at recording the average intensity of pain experienced by the patients after root canal procedure through rotary devices which are not used in common practice by the dentists in our community and comparing it with older techniques such as manual hand files which are more commonly used.
Design
In this non blinded randomized control trial subjects were divided into two interventional groups by lottery method. There were 30 subjects in each. The patients were asked to mark their pain on a Numeric pain intensity scale at 6-, 12-, 24- and 48- hour postoperative intervals.
Settings and conduct
Out-patients in the department of Operative dentistry, Rehman College of Dentistry, Peshawar
Participants/Inclusion and exclusion criteria
The inclusion criteria were patients of both gender of age between 20 to 50`years, incisors and canines with irreversible pulpitis, periodontally sound tooth, with no systemic diseases, no radiographic changes on periapical radiograph and restorable teeth. Excluded were subjects who had taken pain medication 12 hours prior to the treatment. Subjects unable to understand the consent and the procedure itself.
Intervention groups
In the manual instrumentation group the cleaning and shaping of the root canals was done by NiTi K-files. In the rotary instrumentation group cleaning and shaping of the root canals was done by HyflexNiTi rotary system. In order to keep equal apical diameter, the final apical preparation in both groups was kept similar.. The patients were asked to mark their pain on a Numeric pain intensity scale at 6-, 12-, 24- and 48- hour postoperative intervals.
Main outcome variables
Pain perceived by the subject at given time post operative intervals.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230713058771N1
Registration date:2023-07-24, 1402/05/02
Registration timing:retrospective
Last update:2023-07-24, 1402/05/02
Update count:0
Registration date
2023-07-24, 1402/05/02
Registrant information
Name
Asim Qureshi
Name of organization / entity
Ayub medical and dental college
Country
Pakistan
Phone
+92 340 9053423
Email address
asim@ayubmed.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-01, 1400/10/11
Expected recruitment end date
2023-06-30, 1402/04/09
Actual recruitment start date
2022-01-01, 1400/10/11
Actual recruitment end date
2022-12-30, 1401/10/09
Trial completion date
2022-12-30, 1401/10/09
Scientific title
Comparison of the mean post operative pain after manual and rotary instrumentation for root canal treatment of single rooted teeth with irreversible pulpitis and normal periapex
Public title
Comparison of the mean post operative pain after manual and rotary instrumentation for root canal treatment of single rooted teeth with irreversible pulpitis and normal periapex
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Incisors and canines with irreversible pulpitis
Periodontally sound tooth
No systemic diseases
No radiographic changes on periapical radiograph
Restorable teeth
Exclusion criteria:
Patients with mental or physical disability
Patient who has taken analgesic within the last 12 hours
Teeth with malposition
Teeth with fixed partial dentures
Age
From 20 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After proper history taking , investigations and formal consent. Subject was considered in one of our two groups by random allocation (lottery method). In this method each subject was asked to pick a sealed envelope out of the total 60. Each sealed envelope marked which group the subject will be put in. This was not concealed from the subject. This randomization was done by non- probability consecutive sampling.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee at Rehman college of Dentistry
Street address
Plot #5 B2 phase V Hayatabad, Peshawar
City
Peshawar
Postal code
25000
Approval date
2020-07-21, 1399/04/31
Ethics committee reference number
EC-REFNO; 20-07-15
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis of single rooted teeth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain perceived by subject after the root canal treatment
Timepoint
6-, 12-, 24- and 48- hour postoperative intervals.
Method of measurement
Numeric pain intensity scale (handed to patient in printed form)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: cleaning and shaping by manual instruments
Category
Treatment - Devices
2
Description
Intervention group: cleaning and shaping by rotary instruments
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Operative department Rehman college of dentistry
Full name of responsible person
Dr. Nida Gul Sepah
Street address
Plot 5 B2 phase V Hayatabad
City
Peshawar
Postal code
25000
Phone
+92 345 4589890
Email
nidasepah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rehman college of dentistry
Full name of responsible person
Dr. Nida Gul Sepah
Street address
Plot 5 B2 phase 5 hayatabad
City
Peshawar
Postal code
25000
Phone
+92 345 4589890
Email
nidasepah@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rehman college of dentistry
Proportion provided by this source
15
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rehman college of dentistry
Full name of responsible person
Dr. Nida Gul Sepah
Position
Resident
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Plot 5, B2 phase, 5 Hayatabad
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 345 4589890
Email
nidasepah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ayub medical and dental college
Full name of responsible person
Asim Qureshi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Riaz house hill street opposite hotel one
City
Abbottabad
Province
Khyber Pakhtunkhwa
Postal code
224400
Phone
+92 340 9053423
Fax
Email
asimovtm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rehman college of dentistry
Full name of responsible person
Dr. Nida Gul Sepah
Position
Resident
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Plot 5 B2 phase 5 hayatbad
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 345 4589890
Email
nidasepah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcome measure only
When the data will become available and for how long
Once published it will be available .
To whom data/document is available
People in academic institutions only
Under which criteria data/document could be used
Corresponding author will address this on an individual case bases . As requested by any inquire
From where data/document is obtainable
Person to contact for scientific quires.
asimovtm@gmail.com
What processes are involved for a request to access data/document
Applicant needs to provide the reason for the document and how it might be used.