Many patients suffer from mild, moderate or severe pain during or after root canal therapy. The purpose of this study was to evaluate the efficacy of supraperiosteal injection of dexamethasone into the periapical tissues to prevent postoperative pain associated with inflammation. In a triple-blind, placebo-controlled clinical trial, 60 patients with moderate or severe pain who are referred to dental school of Mashhad University of Medical Sciences participate in this study. All patients should have a tooth with clinical diagnosis of irreversible pulpitis or pup necrosis without signs of periapical abcess. After administration of local anaesthesia, the standard treatment of RCT complete. Then, one millilitre dexamethasone (8 mg 2 mL(-1)) or placebo was injected around the tooth. The severity of pain was assessed with regard to a modified visual analogue scale after 6, 12, 24 and 48 h. The data was analysed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109217608N1
Registration date:2012-12-28, 1391/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-28, 1391/10/08
Registrant information
Name
Neda Naghavi
Name of organization / entity
Dental Research Center
Country
Iran (Islamic Republic of)
Phone
+98 511882950115
Email address
naghavin@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University Of Medical Sciences
Expected recruitment start date
2012-02-09, 1390/11/20
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of local injection of Dexamethasone on post endodontic pain
Public title
Dexamethasone effect on post endodontic pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: healthy peaple(ASA I or II); people need endodontic treatment
exclusion criteria: pregnant and lacting women; people under 18; patient with hormonal and infected disorders not related to dental problems; moderate or severe periodontal diseases; acute apicl absses or acute apical periodontitis; retreatment cases
Age
From 18 years old to 149 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2012-03-14, 1390/12/24
Ethics committee reference number
900607
Health conditions studied
1
Description of health condition studied
tooth pain
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
pain value
Timepoint
before treatment, 6,12,24,48 hours after treatment
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
in intervention group: infiltraton injection of Dexamethasone (4mg/1ml), after completion of root canal treatment
in control group: infiltraton injection of placebo ( 1ml ofdistilled water), after completion of root canal treatment
Category
Treatment - Drugs
2
Description
in control group: infiltraton injection of placebo ( 1ml ofdistilled water), after completion of root canal treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry/ Mashhad University of Medical Science
Full name of responsible person
Dr Neda Naghavi
Street address
Faculty of Dentistry, Azadi square, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mozhdeh Ghandeharian
Street address
Dental School, Azadi Square, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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 Research Center
Full name of responsible person
Dr. Neda Naghavi
Position
assistant professor of Dental Research Center
Other areas of specialty/work
Street address
Dental Research Center, Dental School, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 1882 9501
Fax
Email
naghavin@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Research Center, Faculty of Dentistry
Full name of responsible person
Dr. Saeed Moradi
Position
Associate Professor of Endodontics
Other areas of specialty/work
Street address
Endodontics group, Dental School, Azadi Square
City
Mashhad
Postal code
Phone
+98 51 1882 9501
Fax
Email
moradis@mums.c.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Research Center
Full name of responsible person
Dr. Neda Naghavi
Position
assistant professor of Dental Research Center
Other areas of specialty/work
Street address
Denta Research Center, Dental School, Azadi Squar
City
Mashhad
Postal code
Phone
+98 51 1882 9501
Fax
Email
naghavin@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)