Comparison of the effect of prescribing Gelophen on mandibular maxillary third molar surgery on pain reduction after surgery between men and women
Design
This study was non-control group and all patients referred to the diagnosis of impacted third molar with surgical indications and entry conditions were selected.
Settings and conduct
In this clinical trial study, all patients referring to the dental clinic of Khorramabad University of Medical Sciences who have implicated in the evaluation of impacted third molar are included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Impacted mandibular third molar, third molar without caries, third molar without a pericoronitis, a lack of vision of the impacted molar with the eye, an impacted molar that requires surgery to remove the need for piece of bone and teeth.
Exclusion criteria: Having a history of disease, history of digestive diseases, history of systemic diseases such as diabetes, kidney failure, liver failure, history of allergy to aspirin and its similar compounds, patients with a history of addiction, no-referral, non-response of the phone for any reason, incidence of severe complications and patient death, use of drugs with anti-pain and anti-inflammatory properties that interfere with NSAIDs.
Intervention groups
Two Gelofen 400 mg, 1 hours before impacted third molar surgery
Main outcome variables
pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180702040302N1
Registration date:2018-08-01, 1397/05/10
Registration timing:retrospective
Last update:2018-08-01, 1397/05/10
Update count:0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Ehsan Shafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3220 7826
Email address
shafli.e@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-11, 1396/01/22
Expected recruitment end date
2018-04-11, 1397/01/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Gelophen administration on mandibular impacted third molar surgery on pain reduction after surgery between men and women
Public title
evaluation of decreasing pain of impacted wisdom teeth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Impacted mandibular third molar
Third molar without caries
Third molar without a pericoronitis
A lack of vision of the impacted molar with the eye
An impacted molar that requires surgery to remove the need for piece of bone and teeth
Exclusion criteria:
Having a history of disease
History of digestive diseases
History of systemic diseases such as diabetes, kidney failure, liver failure
History of allergy to aspirin and its similar compounds
Patients with a history of addiction
No-referral
Non-response of the phone for any reason
Incidence of severe complications and patient death,
Use of drugs with anti-pain and anti-inflammatory properties that interfere with NSAIDs.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Khorramabad University of Medical Sciences
Street address
Research & Technology Dept, Kamalvand Pardis, Lorestan University of Medical Sciences, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Approval date
2018-05-12, 1397/02/22
Ethics committee reference number
IR.LUMS.REC.1397.026
Health conditions studied
1
Description of health condition studied
Pain control
ICD-10 code
Chapter V
ICD-10 code description
F45.4 Persistent somatoform pain disorder
Primary outcomes
1
Description
Pain intensity
Timepoint
2,4,6,6,8, 12,24,72 hours after surgery
Method of measurement
Standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Two Gelofen 400 mg 1 hours after impacted wisdom teeth
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic, Khorramabad University of Medical Sciences
Full name of responsible person
Dr. Ehsan Shafiei
Street address
Lorestan University of Medical Sciences, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 21 3320 7826
Email
shafli_e@lums.ac.ir
Web page address
http://www.dent.lums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr. Ehsan Shafiei
Street address
Research & Technology Dept, Kamalvand Pardis, Lorestan University of Medical Sciences, Khorramabad, Lorestan,
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 21 3320 7826
Email
shafli.e@lums.ac.ir
Web page address
http://www.dent.lums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr. Mosayeb Masoumi Nejad
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Lorestan University of Medical Sciences, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 21 3320 7826
Email
neda_amani69@yahoo.com
Web page address
http://www.lums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr. Ehsan Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Lorestan University of Medical Sciences, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 21 3320 7826
Email
shafli.e@lums.ac.ir
Web page address
http://www.lums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr. Ehsan Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Lorestan University of Medical Sciences, Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 33207826
Email
shafli.e@lums.ac.ir
Web page address
http://www.lums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD