Aim: eliminating or reducing pain following endodontic treatment is of great importance. The aim of this study is to compare the effects of Tramadol, Novafen and Naproxen on post-operative pain following instrumentation of root canals in teeth with irreversible pulpitis. Sample size: one hundred patients considering the inclusion and exclusion criteria were selected. Exclusion and inclusion criteria: 1. Patients were aged between 20-60 years with no systemic diseases and females were not pregnant, 2. No history of taking any analgesics or other drugs prior to presenting for treatment, and 3. Patients had moderate to severe pain associated with irreversible pulpitis in single-rooted premolars or anterior teeth. Intervention and outcome: The effect of Tramadol, Novafen and Naproxen on post-operative pain following instrumentation of root canals in teeth with irreversible pulpitis was evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903194006N2
Registration date:2010-06-09, 1389/03/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-06-09, 1389/03/19
Registrant information
Name
Payman Mehrvarzfar
Name of organization / entity
Dental Branch of Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
dr.p.mehrvarzfar@dentaliau.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2010-07-01, 1389/04/10
Expected recruitment end date
2010-08-11, 1389/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Tramadol, Novafen and Naproxen on post-operative pain following endodontic treatment
Public title
The effects of Tramadol, Novafen and Naproxen on post-operative pain following endodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged between 20-60 years; Patients with moderate to severe pain associated with irreversible pulpitis in single-rooted premolars or anterior teeth. Exclusion criteria: systemic diseases; pregnancy in women; taking any analgesics or other drugs prior to presenting for treatment.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics committe of Dental School of Tehran Azad University
Street address
No. 4, 10th alley, Pasdaran Ave
City
Tehran
Postal code
Approval date
2010-06-28, 1389/04/07
Ethics committee reference number
7065
Health conditions studied
1
Description of health condition studied
Post operative endodontic pain
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
post operative endodontic pain
Timepoint
before intervention, 6, 12 and 24 hours after treatment
Method of measurement
Visual analogue scale quesionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control: Placebo
Category
Placebo
2
Description
Intervention: group1: Tramadol Tab, 100mg in 6, 12 and 24 hours after root canal treatment
Category
Treatment - Drugs
3
Description
Intervention group 2: Novafen, 325 mg in 6, 12 and 24 hours after root canal treatment
Category
Treatment - Drugs
4
Description
Intervention group 3: Naproxen Tab, 500 mg in 6, 12, and 24 hours afetr root canal treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School of Tehran Azad University
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
No sponsers
Full name of responsible person
Peyman Mehrvarzfar
Street address
10th neyestan, Pasdran Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
No sponsers
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
Endodontic Department, Dental School of Tehran Azad University, Tehran, Iran