The purpose of this study is to evaluate the effect of Amitriptyline and Imipramyne on pain reduction in teeth with symptomatic irreversible pulpitis while preparing access cavity. The patients must have a molar tooth with a pulpal and periapical diagnosis of symptomatic irreversible pulpitis; must be healthy , must not have any systemic disease, must not use any medicaments; must not have any allergy to the drugs used in this experiment; must not use tricycle antidepressant and after the administration of local anesthetic ( lidocaine 2% + 1/100000 epinephrine ) must still experience pain during the preparation of the access cavity. 66 16 to 60 year old patients with these criteria will be evaluated. After getting a informed consent, the level of pain experienced by the patients during access cavity preparation will be assessed by a Mcgill Visual Analog Scale then the patients will be randomly divided into three groups : 1. administration of 0.2 ml Amitriptyline 1mg/ml 2- administration of 0.2ml Imipramyne 1mg/ml 3- control group ( administration of 0.2ml propylene glycol) and 5 minutes after the application of the drugs the degree of pain experienced will be assessed again. The primary expected outcome is decreased pain during access cavity preparation. The study will be a double-blind study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110317963N1
Registration date:2012-04-01, 1391/01/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-01, 1391/01/13
Registrant information
Name
Mohsen Aminsobhani
Name of organization / entity
Tehran University of Medical Sciences, Faculty Of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 0567
Email address
maminsobhani@irimc.org
Recruitment status
Recruitment complete
Funding source
Research Center of Tehran University of Medical Sciences
Expected recruitment start date
2012-04-01, 1391/01/13
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Amitriptyline and Imipramyne on pain reduction in teeth with irreversible pulpitis while preparing access cavity.
Public title
The local effect of two antidepressant drugs on pain reduction in teeth with severe tooth ache ( irreversible tooth pulp inflammation) during root canal therapy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient ( male or female )with a molar tooth with a pulpal and periapical diagnosis of symptomatic irreversible pulpitis; healthy patient with a non-contributory medical history; patient must not use any medicaments; must not have any allergy to the drugs used in this experiment or other tricyclic antidepressant; must not use tricyclic antidepressant; after administration of local anesthetic must still experience pain during the preparation of the access cavity.
exclusion criteria: patient ( male or female ) with any systemic disease; patient using any medicament; patient with allergy to the drugs used in this experiment or other tricyclic antidepressant; use of tricyclic antidepressant; after administration of local anesthetic does experience pain during the preparation of the access cavity.
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Tehran University of Medical Sciences
Street address
Ghods st, Keshavarz Bulevard
City
Tehran
Postal code
1417653761
Approval date
2011-03-15, 1389/12/24
Ethics committee reference number
90-04-69-15772-49211
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Diseases of pulp and periapical tissues-Pulpitis-irreversible
Primary outcomes
1
Description
pain
Timepoint
5 minute after application of the drug
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
0.2 ml Amitriptyline + propylen glycole ( 1mg/ml) is applyed locally on the carious dentin of the tooth and after 5 minutes its effect on the patients pain is assessed
Category
Treatment - Drugs
2
Description
0.2 ml Imipramyne + propylen glycole ( 1mg/ml) is applyed locally on the carious dentin of the tooth and after 5 minutes its effect on the patients pain is assessed
Category
Treatment - Drugs
3
Description
0.2 ml propylen glycole is applyed locally on the carious dentin of the tooth and after 5 minutes its placebo effect on the patients pain is assessed
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty of Tehran University of Medical Sciences
Full name of responsible person
Street address
Dental Faculty of Tehran University of Medical Sciences , North Kargar st
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohsen Aminsobhani
Street address
Research Center of Tehran University of Medical Sciences, Ghods st, Keshavarz Bulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center of Tehran 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
Dental Faculty of Tehran University of Medical Sciences
Full name of responsible person
Mohsen Aminsobhani
Position
Assistant Professor, Endodontist
Other areas of specialty/work
Street address
Department of Endodontics, Dental Faculty of Tehran University of Medical Sciences, North Karegar st.
City
Tehran
Postal code
Phone
+98 21 8835 1173
Fax
Email
maminsobhani@irimc.org maminsobhani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty of Tehran University of Medical Sciences
Full name of responsible person
Mohsen Aminsobhani
Position
Assistant Professor, Endodontis
Other areas of specialty/work
Street address
Department of Endodontics, Dental Faculty of Tehran University of Medical Sciences, North Karegar st
City
Tehran
Postal code
Phone
+98 21 8835 1173
Fax
Email
maminsobhani@irimc.org maminsobhani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty of Tehran University of Medical Sciences
Full name of responsible person
Naghmeh Meraji
Position
Postgraduate, Department of Endodontic
Other areas of specialty/work
Street address
Department of Endodontics, Dental Faculty of Tehran University of Medical Sciences, North Karegar st.
City
Tehran
Postal code
Phone
+98 21 8835 1173
Fax
Email
naghmeh_m82@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)