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Analgesic Efficacy of Ketoprofen Transdermal Patch Versus Ibuprofen Tablet on Post-Endodontic Pain in Patients with Irreversible Pulpitis – A Randomized Clinical Trial

Protocol summary

Study aim
Efficacy evaluation of transdermal ketoprofen patch on post-endodontic moderate to severe pain in single visit treatment of first/second mandibular molar with irreversible pulputis
Design
A randomized, double-blind, parallel group, controlled clinical trial, phase 2. 54 patients divided to 2 groups by stratified permuted blocks method.
Settings and conduct
Patients refer to endodontic section of dental school in Shahid Beheshti University of Medical Sciences receive post-operative patches or tablets to use every 6 hrs in 1 day. Patients pain intensity is measured before the operation and postoperatively in 0, 2, 4, 8,12, 24 and 48 hrs by Numeric Rating Scale. Collected data are analysed by Two way repeated measure ANOVA. all drugs are in unclear and sealed envelops and The investigator, dentist, data collector and analyzer are blinded in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18-65 years , ASA I physical status, first/second maxillary/mandibular molar with irreversible pulpitis, Exclusion criteria: any systemic disorders, using any analgesic drug in the past 12 hrs, gastrointestinal diseases or allergy to NSAIDS, allergy to local anesthetic drugs or sulfite.not being able to give informed consent or to read and pregnant or breastfeeding women. inappropriate teeth for restoration or teeth with severe periodontal disease, swelling or fistula or spontaneous pain. Exit criteria include disability in patient's fallow-up, inappropriate endodontic treatment and using other analgesics drugs.
Intervention groups
In the first intervention group, a transdemal ketoprofen patch is applied every 6 hours for 1 day after root canal treatment. In the second intervention group, ibuprofen is used every 6 hours for 1 day after root canal treatment.
Main outcome variables
Post-operative pain control in root canal treatment using ketoprofen patch or ibuprofen tablet

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190716044230N1
Registration date: 2020-04-21, 1399/02/02
Registration timing: prospective

Last update: 2020-04-21, 1399/02/02
Update count: 0
Registration date
2020-04-21, 1399/02/02
Registrant information
Name
Saeede Zadsirjan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2241 3896
Email address
s_sirjani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic Efficacy of Ketoprofen Transdermal Patch Versus Ibuprofen Tablet on Post-Endodontic Pain in Patients with Irreversible Pulpitis – A Randomized Clinical Trial
Public title
Analgesic Efficacy of Ketoprofen Transdermal Patch Versus Ibuprofen Tablet on Post-Endodontic Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients whom their physical status is classified as ASA I Mandibular first/second molar diagnosed as irreversible pulpitis with moderate to severe pain Positive response to electric pulp test, lingering pain to cold test which validate the diagnosis of irreversible pulpitis for each tooth
Exclusion criteria:
Having any systemic disorders, gastrointestinal disease or allergy which interfere with NSAIDS Allergy to local anesthesia drugs or sulfite Teeth that are not appropriate to be restorated or teeth with severe periodontal disease which are not suitable for endodontic treatment Patients with swelling or fistula Using any analgesic drug in the past 12 hours Spontaneous pain which requires emergency treatment Not being able to give informed consent or not being able to read and write Pregnant or breastfeeding women Exit criteria include disability (for any reason) in patient's fallow-up, inappropriate endodontic treatment or a two visit treatment and using other analgesics along with the study drugs.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: block Unit of randomization: stratified Randomization strata: sex, teeth(first molar/second molar) Tools used in randomization: sealed envelops How the random sequence was built: permutation Allocation concealment: all the drugs are packed in same unclear sealed envelops which is not distinguishable for the researcher. This process is done by a third person that is unaware of the object and protocol of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Dentist: he is not aware of the randomization and can not distinct drug packs because of their same appearance. principal investigator and data collectors: are not aware of the randomization. Outcome assessors: are not aware of the randomization.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti university of medical sciences
Street address
Shahid Beheshti Dental school, Daneshjou blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2020-01-28, 1398/11/08
Ethics committee reference number
IR.SBMU.DRC.REC.1398.226

Health conditions studied

1

Description of health condition studied
Irreversible pulpitis (dental)
ICD-10 code
K04.99
ICD-10 code description
Other diseases of pulp and periapical tissues

Primary outcomes

1

Description
Pain intensity after root canal treatment
Timepoint
Pain measurement immediately after root canal treatment and 2, 4, 8,12, 24 and 48 hours after treatment
Method of measurement
Numerical rating scale (NRS)

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention group: Name of the drug: Ketoprofen, How to use: Skin patch (patches with the trademark Ketoclin from Sinsin pharm company), Patch concentration: 60 mg, Frequency: Every 6 hours, Duration: 24 hours. Additional Description: Patch Placement: Hairless areas on the arm or forearm
Category
Treatment - Drugs

2

Description
Second Intervention group: Name of the drug: Ibuprofen, How to use: Oral tablets (Made by Tehran chemie company), Tablet concentration: 400 mg, Frequency: Every 6 hours, Duration: 24 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental faculty of Shahid Beheshti university of medical sciences
Full name of responsible person
Saeede Zadsirjan
Street address
Endodontic Department, Shahid Beheshti Dental school, Daneshjou Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2241 3896
Email
DentalSchoolInfo@sbmu.ac.ir
Web page address
http://dentistry.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Tehranchi
Street address
Shahid Beheshti Dental school, Daneshjou blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2241 3896
Fax
Email
DentalSchoolInfo@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeede Zadsirjan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Dental school, Daneshjou blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2241 3896
Email
S_sirjani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeede Zadsirjan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Dental school, Daneshjou blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2241 3896
Email
S_sirjani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeede Zadsirjan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Dental school, Daneshjou blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2241 3896
Email
S_sirjani@yahoo.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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
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