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Assessment of the effect of aspirin on levels of lipoxin A4، interleukin-1β and prostaglandin E2 in periapical exudates: a double blinded randomized clinical trial

Protocol summary

Study aim
The effect of aspirin on the levels of lipoxin A4, interleukin β1 and prostaglandin E2 in periapical exudate
Design
Clinical trial with control group, parallel, double-blind, randomized
Settings and conduct
After anesthesia injection, teeth were isolated with rubber dam. The penetrating chamber with fissure bur. The length of operation after measurement with apex locator is confirmed by radiography. Canal cleaning and shaping is performed according to the protaper system up to F3 size. the canal is washed with 2 ml of normal saline and dried with paper cone.A paper cone No. 40 is inserted into the canal for approximately the length of operation. 3 mm end of it is separated and placed in an ependorf containing PBS ,samples are stored at -70 ° C. After 7 days,sampled similar to the first session, and the canal will be cleaned, shaped and obturated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with good general health, patients aged 18-45 years, all single root canals, distal mandibular molars and palatal roots of maxillary molars with periapical lesion of >5 mm in diameter, teeth No history of trauma and previous root canal treatment. Exclusion criteria included: 1- non-isolated teeth, 2- presence of periodontal disease, 3- presence of systemic disease, 4-history or presence of other infections, 5-specific physiological conditions, 6-oral ulcers, 7-smokers and Alcohol, 8-gastrointestinal problems, 9-treatment with any drug during the past week, and 10-allergy to salicylates or other non-acute anti-inflammatory drugs.
Intervention groups
Patients in the 7 groups receive 7 mg aspirin tablets for 7 days. The placebo was administered similarly to the case group for 7 days.
Main outcome variables
Group, Mediator concentration of lipoxin A4, Mediator concentration of Interleukin β1, Mediator concentration of prostaglandin E2

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191211045702N1
Registration date: 2019-12-23, 1398/10/02
Registration timing: prospective

Last update: 2019-12-23, 1398/10/02
Update count: 0
Registration date
2019-12-23, 1398/10/02
Registrant information
Name
Razieh Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1086
Email address
razieh.salehi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of aspirin on levels of lipoxin A4، interleukin-1β and prostaglandin E2 in periapical exudates: a double blinded randomized clinical trial
Public title
Assessment of the effect of aspirin on periapical inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with good general health Patients aged 18-45 years All single root, distal root of mandibular molars and palatal root of maxillary molars with periapical lesion of >5 mm in diameter Tooth with no history of trauma and previous root canal treatment
Exclusion criteria:
Unable to isolate tooth Presence of periodontal disease Presence of systemic disease History or presence of other infections Specific physiological conditions Oral ulcer Smokers and alcoholics Gastrointestinal problems Treatment with any drug over the past week Sensitivity to salicylates or other non-steroidal anti-inflammatory drugs
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
periapical exudate
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with size 4
Blinding (investigator's opinion)
Double blinded
Blinding description
The random process will be performed by someone outside the core research team, and the patient and physician will not know which group the patient is in.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Ave, dentistry school
City
Hamadan
Province
Hamadan
Postal code
65417838741
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.UMSHA.REC.1398.692

Health conditions studied

1

Description of health condition studied
Apical periodontitis
ICD-10 code
K04.5
ICD-10 code description
Chronic apical periodontitis

Primary outcomes

1

Description
Concentration of inflammatory mediator
Timepoint
At baseline and 7 days later
Method of measurement
Enzyme-linked immunosorbent kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 7 pills of aspirin 80 mg for 7 days
Category
Treatment - Drugs

2

Description
Control group: 7 tablets containing sodium saccharin for 7 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dentistry school
Full name of responsible person
Elham Khoshbin
Street address
Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1086
Fax
+98 81 3838 1085
Email
elham.khoshbin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Hamedan University of Medical Sciences
Full name of responsible person
Razieh Salehi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1086
Email
r.salehi70510@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Razieh Salehi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Endodontics Department, Dental University, Shahid Fahmideh Ave, Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1086
Fax
Email
razieh.salehi@edu.umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Razieh Salehi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Endodontics Department, Dental University, Shahid Fahmideh Ave, Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1086
Fax
Email
razieh.salehi@edu.umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Results of the main outcome include the concentation of inflammatory mediators in the periapical exudate
When the data will become available and for how long
after publication of the final article
To whom data/document is available
En researchers who works in university
Under which criteria data/document could be used
the data will provide for using in review studies or future clinical trials if cited as regular
From where data/document is obtainable
r.salehi70510@gmail.com, 09171435936,Razieh Salehi
What processes are involved for a request to access data/document
requesting via email that takes maximum one month after receiving the request
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