Pain is among the clinical symptoms of apical acute periodontitis, which could happen spontaneously, moderate to severe, or pain during the contact with the opposite tooth. In order to control the endodontic teeth effectively and based on systematic principles, reaching a diagnosis and then the appropriate treatment such as the drainage of abscess or pulpectomy in case of irreversible inflammation of tooth pulp. Eventually, the suitable medication would be applied in order to decrease the patient’s pain. In order to have new components of the medications, to lessen the patient’s pains either temporarily or permanently, in this study, the analgesic effect of Acetaminophen and Codeine Acetaminophen in the presence of Caffeine in order to control the pain of acute apical periodontitis were compared. This is a double-blind study.There were 60 patients selected based on the criteria for their inclusion (suffering from severe pain…) and exclusion from the study (suffering from systematic diseases) and divided into 4 groups of 15 subjects. A single dosage was prescribed for each patient: 1. Simple Acetaminophen 325 Mg. + Caffeine 50 Mg. 2. Simple Acetaminophen 325 + Caffeine 100 Mg. 3. Codeine Acetaminophen 15 mg (+ 325 mg) + Caffeine 50 Mg.
4. Codeine Acetaminophen 15 mg (+ 325 mg) + Caffeine 100 mg every 10 mins after the drug consumption according to Visual Analog Scale (VAS( was checked by the patient. During the treatment, the patient was analyzed in terms of the side effects of the medication. At the end, the procedure of the pain was analyzed in different times and a linear graph was drawn for each group. After the investigation and information codes analysis, results in terms of pain reduction was measured in the apical periodontitis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304121760N22
Registration date:2013-08-24, 1392/06/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-24, 1392/06/02
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2004-03-17, 1382/12/27
Expected recruitment end date
2005-01-16, 1383/10/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of Acetaminophen and Acetaminophen Codeine with caffeine in control of control preapical periodontitis pain
Public title
Comparison of analgesic effect of Acetaminophen and Acetaminophen Codeine with caffeine in control of control preapical periodontitis pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having severe pain scale of 7; Patient's ability to read, write and understand the concept of Visual Analog Scale; Non-housing consumption of 4 hours before the study, aged between 16 and 65 years.
Exclusion criteria:
A systemic disease.
Age
From 16 years old to 65 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical sciences, Gangafroz Avenue
City
Babol
Postal code
4717641367
Approval date
2004-03-15, 1382/12/25
Ethics committee reference number
1153
Health conditions studied
1
Description of health condition studied
Acute apical periodontitis pain
ICD-10 code
K04.4
ICD-10 code description
Acute apical periodontitis of pulpal origin
Primary outcomes
1
Description
Acute apical periodontitis pain
Timepoint
Every 10 minutes up to 120 minutes after drug
Method of measurement
Scale Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Group Intervention 1.
Simple acetaminophen 325mg+caffeine 50mg
(Acetaminophen used in the manufacture of pharmaceutical company Galen)
Category
Treatment - Drugs
2
Description
Group Intervention 2.
Simple acetaminophenc 325mg +caffeine 100mg
(Acetaminophen used in the manufacture of pharmaceutical company Galen)
Category
Treatment - Drugs
3
Description
Group Intervention 3.
Acetaminophen codeine(325mg +15mg) + Caffeine 50mg
( Codeine acetaminophen used in the manufacture of pharmaceutical company Galen)
Category
Treatment - Drugs
4
Description
Group Intervention 4.
Acetaminophen codeine (325mg +15mg) + Caffeine 100mg (Acetaminophen codeine used in the manufacture of pharmaceutical company Galen)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The diagnosis and endodontic dental colleges of Babol
Full name of responsible person
Dr. Hosein-Ali Mahran
Street address
Dental Colleges of Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Ganjafroz Avenue, Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
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, Babol 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 Colleges Of Babol
Full name of responsible person
Dr. Elham Mahmoodi
Position
Resident Endo
Other areas of specialty/work
Street address
Ganjafroz Avenue, Babol University of Medical Sciences, Dental College
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
dr.elhammahmoodi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental College of Babol
Full name of responsible person
Dr. Zahra-Sadat Madani
Position
Endodontist
Other areas of specialty/work
Street address
Ganjafroz Avenue,Babol University of Medical Sciences, Dental College
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
dr.elhammahmoodi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Infertility & Reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible of Reseach Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & Reproductive Health Reseach Center, Noshirvani steert
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)