Introduction: Pain management is very important in endodontic practice. The aim of this study is to compare the effect of pain relief of on-demand versus regular prescription of ibuprofen after two-visit retreatment in molar teeth.
methods: seventy maxillary or mandibular molar teeth that need retreatment will have two-visit root canal retreatment. after this treatment, patients will be randomly allocated to 2 groups of 35 patients each. patients in group 1 will receive a single dose of 400 mg ibuprofen and a rescue bag of the same medication. patients in group 2 will receive the same medication as group 1 after treatment and they will be also provided with a prescription to use 400 mg ibuprofen every 6 hours for at least 24 hours. the patients will be asked to rate their pain on a visual analog scale for up to 48 hours after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611242016N8
Registration date:2016-12-04, 1395/09/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-04, 1395/09/14
Registrant information
Name
Masoud Parirokh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1245 7931
Email address
m_parirokh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Kerman University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between prescription of regular or on-demand Ibuprofen on postoperative pain after two visit retreatment of molar teeth
Public title
effect of different factors on post retreatment pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: healthy patients with first or second molar with previous root canal therapy that need retreatment without sensitivity in percussion or with mild sensitivity, with or without periapical radiolucency, without severe periodontal disease in the tooth,
exclusion criteria: patients with systemic disease, sensitivity to ibuprofen, gasteric disease, pregnancy, the hopeless tooth, third molar( wisdom tooth), severe periodontal disease in the tooth, use of any pain killer in 12 hours ago, use of any drug that effect in the central nervous system, addicted persons, over instrumentation RCT, patient under 18 years old
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Kerman University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Tahmasbabad Cross road
City
kerman
Postal code
Approval date
2009-05-18, 1388/02/28
Ethics committee reference number
ir.kmu.REC.1395.12
Health conditions studied
1
Description of health condition studied
retreatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative pain
Timepoint
Six, 12, 24, 48 hours following the treatment
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Analgesic consumption
Timepoint
48 hours following the treatment
Method of measurement
Using a specific form
Intervention groups
1
Description
case group 1: use of ibuprofen (minoo jel) 400 mg on demandcase
Category
Treatment - Drugs
2
Description
group 2: use of ibuprofen (minoo jel) 400 mg by the clock
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontic Department, Kerman Dental School
Full name of responsible person
Street address
City
kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Tahmasbabad cross road, Vice Chancellor for Research and Technology building Kerman
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology
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
Vice Chancellor for Research and Technology
Full name of responsible person
Dr. Abbas pardakhti
Position
Dean of the center
Other areas of specialty/work
Street address
Tahmasbabad cross road, Vice Chancellor for Research and Technology building Kerman
City
kerman
Postal code
Phone
+98 34 3226 3815
Fax
Email
kmu_research@yahoo.com 63
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endodontics Department, School of Dentistry
Full name of responsible person
Masoud Parirokh
Position
Full Professor
Other areas of specialty/work
Street address
Endodontic Department, School of Dentistry, Shafa street
City
kerman
Postal code
Phone
+98 34 3245 7931
Fax
Email
masoudparirokh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman School of Dentistry
Full name of responsible person
Nargessalsadat Kashi
Position
Postgraduate student
Other areas of specialty/work
Street address
School of Dentistry, Shafa street
City
Kerman
Postal code
Phone
Fax
Email
nargessadat.kashi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)