Comparison of the effect of premedication with two drugs:oral Dextrometorphan and Ibuprofen on post root canal therapy pain in pateints with irriversible pulpitis in first mandibular molar.
None steroidal anti-inflammatory drugs are the most commonly used analgesics with gastrointestinal side effects. The researchers are looking for alternative drugs with fewer side effects. This study aims to determine the effect of the oral Dextromethorphan (N-methyl-D-aspartate receptor antagonist) in comparison with Ibuprofen in pain after root canal therapy.
This double-blind randomized clinical trial has placebo controlled. Research will be done on healthy patients need endodontic treatment of first lower molar with irreversible pulpitis, spontaneous pain and no apical lesions. Patients are excluded with necrotic tooth or inability to complete treatment in one visit.45 patients participate in this research. Randomly, patients are given a single dose of dextromethorphan, ibuprofen, or placebo an hour before the beginning of treatment and receiving anesthesia. Then root canal treatment is completed in one visit. Pain intensity is evaluated by a questionnaire according to the visual analogue scaling method at intervals of 2, 4, 8 and 12 hours after root canal treatment.
The patients are asked to mark in the questionnaire if they take analgesics, ultimately these patients will be excluded. Questionnaires are collected in the crown restoration appointment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070228732N1
Registration date:2017-04-23, 1396/02/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-23, 1396/02/03
Registrant information
Name
Elmira Ahmadpour
Name of organization / entity
Isfahan islamic azad university-khprasgan branch
Country
Iran (Islamic Republic of)
Phone
+98 31 3531 0552
Email address
e.ahmadpour@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
ّIsfahan Islamic Azad University Khorasgan branch
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2017-09-11, 1396/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of premedication with two drugs:oral Dextrometorphan and Ibuprofen on post root canal therapy pain in pateints with irriversible pulpitis in first mandibular molar.
Public title
The effect of premedication on post root canal therpy pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients with systemic health; suffered from irreversible pulpitis with spontaneous pain in the lower first molar; The patient didn't get analgesics 12 hours before the treatment ; Have only one painful tooth; Tooth without radiographic radiolucency; viewing vital pulp during access cavity preparation; Possibility of completing treatment in one visit.
Exclusion criteria:Patients with systemic disease; patients who took analgesics 12 hours before the treatment; Teeth with apical radiographic radiolucency ;necrotic tooth; Not possible to complete the treatment in one visit.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Treatment is done by two Endodontics with crown down technique.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Islamic Azad University khorasgan branch
Street address
Islamic Azad University, khorasgan, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2017-03-09, 1395/12/19
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1395.13
Health conditions studied
1
Description of health condition studied
Toothache
ICD-10 code
G50-10
ICD-10 code description
Atypical facial pain
Primary outcomes
1
Description
pain after root canal therapy
Timepoint
2,4,6,8 hours after intervention.
Method of measurement
Visual Analog Scaling
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
intervention:oral Dextrometorphan,30 mgr,single dose,1 hour before root canal therapy.
Category
Treatment - Drugs
2
Description
intervention:oral Ibuprofen,600 mgr,single dose,one hour before root canal therapy.
Category
Treatment - Drugs
3
Description
control:placebo,single dose,one hour before root canal therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private clinic in Isfahan
Full name of responsible person
Dr Maryam Zare Jahromi
Street address
no 601, 6th floor, Faraz building, In front of Shariati clinic, Shariati street, Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
private clinic in Isfahan
Full name of responsible person
Dr kamal Amini
Street address
no 3, Yas building, In front of Asemane haftom travel agancy, Mir street, Nazar crossroads, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Islamic Azad University khorasgan branch
Full name of responsible person
Elmira Ahmadpour
Street address
Islamic Azad University, Khorasgan, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Islamic Azad University khorasgan branch
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
Isfahan Islamic Azad University khorasgan branch
Full name of responsible person
Elmira Ahmadpour
Position
Post Graduate Student of Endodontics
Other areas of specialty/work
Street address
Isfahan Islamic Azad University, khorasgan branch, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 383334191
Fax
Email
e.ahmadpour@khuisf.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Isalamic Azad University khorasgan branch
Full name of responsible person
DR Maryam Zare Jahromi
Position
Assistant Professor of Endodontics Department of Isfahan Azad University
Other areas of specialty/work
Street address
Islamic Azad University, khorasgan
City
Isfahan
Postal code
Phone
+98 913 307 9303
Fax
Email
hiva1348maryam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
ISlamic Azad َUniversity Khorasgan Branch
Full name of responsible person
Elmira Ahmadpour
Position
Post Graduate student of Endodontics
Other areas of specialty/work
Street address
Islamic Azad َUniversity, khorasgan, Isfahan
City
Isfahan
Postal code
Phone
+98 35354123
Fax
Email
e.ahmadpour@khuisf.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)