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Comparison of prophylactic effect of Ibuprofen and Novafen with placebo on pain relief in patients requiring endodontic treatment

Protocol summary

Summary
Objectives: Comparison of prophylactic effect of Ibuprofen and Novafen on pain relief after endodontic treatment in patients referred to Salamat clinic of Qom. Design: Randomized, double blinded, placebo controlled, single center, phase 4 trial. Study population: patients requiring endodontic treatment. The inclusion criteria: Age range of 18 to 65 years old; having teeth with alive pulps and no periapical lesion; moderate to severe dental pain at reception (VAS>4). The exclusion criteria: Pregnancy; lactation; history of allergy to NSAID or sulfonamides; history of asthma; chronic use of analgesic; alcohol consumption; having systemic diseases; having cancer or severe abnormalities; use of any analgesic during 12 hours before starting intervention; current smoker. Sample size: 96. Intervention: Novafen, capsule 200 mg oral, once, 1 hour before root canal therapy. Ibuprofen, capsule 400 mg oral, once, 1 hour before root canal therapy. Placebo, capsule oral, once, 1 hour before root canal therapy. Outcome: severity of dental pain, number of analgesic used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031032984N1
Registration date: 2017-07-01, 1396/04/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-01, 1396/04/10
Registrant information
Name
Atieh sadat Rezaei
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 762 0801
Email address
sgholizade@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-05-24, 1396/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylactic effect of Ibuprofen and Novafen with placebo on pain relief in patients requiring endodontic treatment
Public title
Effect of Ibuprofen and Novafen on pain relief after endodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: Age range of 18 to 65 years old; having teeth with alive pulps and no periapical lesion; moderate to severe dental pain at reception (VAS>4) The exclusion criteria: Pregnancy; lactation; history of allergy to NSAID or sulfonamides; history of asthma; chronic use of analgesic; alcohol consumption; having systemic diseases; having cancer or severe abnormalities; use of any analgesic during 12 hours before starting intervention; current smoker
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Oom University of Medical Sciences
Street address
Qom University of Medical Sciences, Saheli street, Qom
City
Qom
Postal code
3713649373
Approval date
2016-08-13, 1395/05/23
Ethics committee reference number
IR.MUQ.REC.1395.81

Health conditions studied

1

Description of health condition studied
Relation of prophylactic effect of Ibuprofen and Novafen on pain relief after endodontic treatment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Severity of dental Pain
Timepoint
Before treatment, 6 hour after treatment, 12 hour after treatment, 24 hour after treatment, 48 hour after treatment
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Number of analgesic used
Timepoint
24 hour after treatment, 48 hour after treatment
Method of measurement
Patients report

Intervention groups

1

Description
Novafen, capsule 200 mg oral, once, 1 hour before root canal therapy
Category
Treatment - Drugs

2

Description
Ibuprofen, capsule 400 mg oral, once, 1 hour before root canal therapy
Category
Treatment - Drugs

3

Description
Placebo, capsule oral, once, 1 hour before root canal therapy
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Salamat clinic, Qom University of Medical Sciences
Full name of responsible person
Street address
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr Hossein Saghafi
Street address
Number 83, Alley 4, Alley 1.1, Safashahr street
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences
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
Qom University of Medical Sciences
Full name of responsible person
Atieh sadat Rezaei
Position
doctor student
Other areas of specialty/work
Street address
Salamat Clinic, Bajak street, Qom
City
Qom
Postal code
Phone
+98 25 3612 2053
Fax
Email
amir.sad313@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Sedighe Gholizade
Position
Medical Doctor
Other areas of specialty/work
Street address
Qom University of Medical Sciences, Saheli street, Qom
City
Qom
Postal code
Phone
+98 25 3770 0094
Fax
Email
sgholizade@muq.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Atieh sadat Rezaei
Position
Doctor student
Other areas of specialty/work
Street address
Salamat Clinic, Bajak street, Qom
City
Qom
Postal code
3719964797
Phone
+98 25 3612 2053
Fax
Email
amir.sad313@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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