The aim of this study was to determine if occlusal reduction can reduce
post-operative pain to increase the comfort of the patient.
Design
In this clinical trial once informed consent was taken each subject was allotted a group with the help of lottery method randomization. This was non concealed and non blinded from the subject. Sample collection was done on non- probability consecutive technique. Subjects were asked to record their pain perceived on the visual analogue scale at 24 th hour in both groups. Which was explained to them before hand.
Settings and conduct
Operative dentistry and Endodontic department Rehmat Memorial Dental Teaching
Hospital Abbottabad. It was a non blinded study and sample collected on non probability consecutive sampling.
Participants/Inclusion and exclusion criteria
INCLUSION ; Patients having maxillary and
mandibular posterior teeth with symptomatic apical periodontitis, teeth that tender
to percussion, having moderate to severe pre-operative both gender and age 18
and above are included in the study.
EXCLUSION ; Teeth with no opposing tooth, and patients
presenting with swelling and sinus were excluded.
Intervention groups
In the intervention group 2mm of occlusal reduction of the tooth will be done after first visit of endodontic treatment i.e. cleaning and shaping of canals
Main outcome variables
Pain perceived by the subject at the 24 th hour. Recorded on the visual analogue scale .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171123037603N1
Registration date:2023-07-28, 1402/05/06
Registration timing:retrospective
Last update:2023-07-28, 1402/05/06
Update count:0
Registration date
2023-07-28, 1402/05/06
Registrant information
Name
Asim qureshi Qureshi
Name of organization / entity
Ayub medical and dental college
Country
Pakistan
Phone
+92 340 9053423
Email address
asimovtm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-12-30, 1400/10/09
Actual recruitment start date
2022-02-01, 1400/11/12
Actual recruitment end date
2022-10-30, 1401/08/08
Trial completion date
2022-10-30, 1401/08/08
Scientific title
EFFECT OF OCCLUSAL REDUCTION ON POSTOPERATIVE PAIN IN TEETH WITH SYMPTOMATIC APICAL PERIODONTITIS FOLLOWING ENDODONTIC INSTRUMENTATION
Public title
Effect of occlusal reduction on postoperative pain in teeth with symptomatic apical periodontitis following endodontic treatment.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Mandibular and maxillary posterior teeth with symtomatic apical periodontitis
Teeth that and tender to percussion
Exclusion criteria:
Teeth without an opposing tooth
Teeth associated with facial swelling
Teeth associated with sinus
Age
From 18 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 informed consent taken from the subjects . Each individual was allotted an intervention group with the help of lottery method. This lottery method was conducted with the help of computer software. No concealment was done from the participant.
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
The ethical committee at Rehmat Memorial Post graduate Dental Teaching Hospital
Street address
Supply Bazar , Main road
City
Abbottabad
Postal code
224400
Approval date
2021-05-20, 1400/02/30
Ethics committee reference number
REF.NO.WMC/RMDTH/EC/2083
Health conditions studied
1
Description of health condition studied
Patients with mandibular or maxillary posterior teeth with symptomatic apical periodontitis.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain perceived by subject
Timepoint
24 hours after the procedure.
Method of measurement
Visual analogue scale (VAS) printed and handed to subject.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Occlusal reduction
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Operative and Endodontic department Rehmat Memorial Dental Teaching Hospital
Full name of responsible person
Dr. Khadija Jahanzeb
Street address
Supply Bazar , Main road
City
Abbottabad
Postal code
224400
Phone
+92 992 390337
Email
jahanzeb.khadija@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rehmat Memorial Dental Teaching Hospital.
Full name of responsible person
Dr. Khadija Jahanzeb.
Street address
Supply Bazar , Main road
City
Abbottabad
Postal code
224400
Phone
+92 992 390337
Email
jahanzeb.khadija@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rehmat Memorial Dental Teaching Hospital.
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
Ayub medical college
Full name of responsible person
Asim qureshi 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
Email
asimovtm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ayub medical and dental college
Full name of responsible person
Asim qureshi Qureshi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Main manshera road Abbottabad
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
Ayub medical and dental college
Full name of responsible person
Asim qureshi Qureshi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Main manshera road Abbottabad
City
Abbottabad
Province
Khyber Pakhtunkhwa
Postal code
224400
Phone
+92 340 9053423
Fax
Email
asimovtm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
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
Only data entered in SPSS/ Excel sheets will be shared not individual sheets.
When the data will become available and for how long
After publication of data it will be available.
To whom data/document is available
Whoever requests the corresponding author with justification for the requirement
Under which criteria data/document could be used
Corresponding author will decided depending on the request. Keeping in mind the best interest of the participants.
From where data/document is obtainable
asimovtm@gmail.com
What processes are involved for a request to access data/document