Comparison between different ibuprophen formulations with two prescription methods on postoperative pain after root canal treatment of teeth with symptomatic irreversible pulpitis; a double blind randomized clinical trial
1-objectives:Comparison between different ibuprophen formulations with two prescription methods on postoperative pain after root canal treatment of teeth with symptomatic irreversible pulpitis
2.design:4groups of 30 people are selected double blined and randomise.
3.setting and conduct:using the random number table,patients will be selected and given medication.
4.participants including major eligibility criteria:age,type of pulpitis,systemic diseases.
5.intervention:patients use ibuprofen or ibuprofen lysine regulary or as needed.
6.main outcome measures:pain level every 6 hours to 72 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051934030N1
Registration date:2017-07-24, 1396/05/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-24, 1396/05/02
Registrant information
Name
sanaz Beyraghdar kashkooli
Name of organization / entity
shahid beheshti dental school
Country
Iran (Islamic Republic of)
Phone
+98 71 3633 3120
Email address
s_beyraghdar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between different ibuprophen formulations with two prescription methods on postoperative pain after root canal treatment of teeth with symptomatic irreversible pulpitis; a double blind randomized clinical trial
Public title
Effect of ibuprofen and ibuprofen lysine on pain after root canal treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1.Healthy patient with a first or second mandibular or maxillary molar tooth with irreversible
pulpitis and have moderate to sever pain to the cold pulp test at the time of treatment and do not have periapical radiolucency appearance without sensivity to percussion.
2.All the patient have no clinical swelling.
3.No patient had a draining sinus tract.
4.A positive response to an electrical pulp teste in addition to a prolonge response with moderate to sever pain to a cold pulp test ( endo-Ice) confirmed the clinical diagnosos of acute irreversible pulpitis for each tooth.
exclusion criteria :
1.Patients under 18.
2.The presence of any systemic disorders sensivity that prevent the use of ibuprophen.
3.Patient are allergic to local anesthetetics or sulfites.
4.Having a tooth not suitable for restoration or having serious pweriodontal disease that render the tooth unsuitable for endodontic treatment.
5.Patients who have use any type of analgesic medication.
6.Patient are unable to give informed consent.
7.Pregnant patient or breast fiding during study.
8.Failure to provide pain relief.
9.History of peptic ulcer or GI bleeding.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
random numbers table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti universsty of medical sciences, dental school
Street address
Tehran-velenjak-daneshjoo boulevard
City
Tehran
Postal code
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
IR.SBMU.RIDS.REC.1395.398
Health conditions studied
1
Description of health condition studied
Pain after root canal treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain after root canal treatment
Timepoint
every 6 hour to 72 hour after root canal treatment
Method of measurement
Visual analogue scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
intervention group1: will use Ibuprophen 400 mg or Ibuprophen lysine 400g regulary every 6 hours at least 24 hours.
Patients should mark the severity of their pain in the VAS.
Category
Treatment - Drugs
2
Description
intervention group 2:will use Ibuprophen 400 mg or Ibuprophen lysine 400g , if necessary.
In the patients description the maximum dose is prescribed.
Patients should mark the severity of their pain in the VAS.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid beheshti university of medical sciences-dental school-department of endodantics
Full name of responsible person
Dr ali haeri tabatabaei
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shahid beheshti dental school
Full name of responsible person
sanaz beyraghdar kashkooli
Street address
tehran-jamalzadeh south-shahid beheshti detal school internationl branch
City
tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shahid beheshti dental school
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
Shahid beheshti dental school
Full name of responsible person
dr Ali haeri tabatabaei
Position
Endodontist/assistant professor
Other areas of specialty/work
Street address
Velenjak-daneshjoo boulevard-shahid beheshti dental school
City
Tehran
Postal code
1985717443
Phone
+98 21 2217 5350
Fax
Email
Ali9352@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid beheshti dental school
Full name of responsible person
dr Saeedeh zadsirjan
Position
Endodontist/assistant professor
Other areas of specialty/work
Street address
Velenjak-daneshjoo boulevard-shahid beheshti dental school
City
Tehran
Postal code
1985717443
Phone
+98 21 2217 5350
Fax
Email
S_sirjani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid beheshti dental school
Full name of responsible person
Sanaz beyraghdar kashkooli
Position
Dental student
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 6692 6409
Fax
Email
Sanazbg72@gmail.com
S_beyraghdar@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)