Comparison of two drugs in controlling pain and swelling after open sinus lift surgery(clinical trials)
Design
Phase three clinical trial with control group،With parallel groups،Two blind strains, randomized into two groups
Settings and conduct
This study is a double-blind clinical trial on 90 patients referred to the surgical department of the dental school Islamic Azad University and a candidate for open sinus lift surgery was performed in 1399
Participants/Inclusion and exclusion criteria
1.range ages 18-40 2.informed consent 3.Candidate for open sinus lift surgery ؛
1.Pregnancy and lactation2.Tobacco consumption 3.Immune system defects
Intervention groups
Ninety patients who referred to Tehran Azad School of Dentistry were randomly divided into two groups of 45 patients. Participants in the study should be available at the times needed to assess pain control (by telephone) and edema control (in person). Otherwise excluded from the investigation. The selection of samples continued until the desired quorum was reached. The case group was treated with 500 mg amoxicillin and 200 mg curcumin after surgery. In the control group, participants in the study were given 500 mg of mefenamic acid and 500 mg of amoxicillin after surgery. All tablets were packaged in the same coating and there was no difference between the appearance of the drugs in either group.
Main outcome variables
Control of pain and swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210215050366N1
Registration date:2021-02-21, 1399/12/03
Registration timing:prospective
Last update:2021-02-21, 1399/12/03
Update count:0
Registration date
2021-02-21, 1399/12/03
Registrant information
Name
Somayeh Alirezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2282 1160
Email address
s.alirezaei@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-28, 1399/12/10
Expected recruitment end date
2021-03-14, 1399/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two drugs in controlling pain and swelling after open sinus lift surgery(clinical trials)
Public title
Comparison of two drugs in controlling pain and swelling after open sinus lift surgery(clinical trials)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-40 age
Informed consent
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected by available and non-probabilistic methods and from among them, patients who meet the inclusion criteria will be selected. Then patients will be divided into two groups of control and intervention by simple random method (code is assigned to each sample) and using SPSS statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of which treatment group they are. The outcome measurer is different from whom that cures patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Medical Sciences, Tehran
Street address
Pasdaran Ave،neyestan 9th،Tehran Azad Dental School
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.225
Health conditions studied
1
Description of health condition studied
Control of pain and swelling after open sinus lift surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Control of pain and swelling after open sinus lift surgery
Timepoint
Repeat doses of the drug every 8 hours for 7 days
Method of measurement
Visual pain scale (VIsual analogue scale) was used to evaluate the pain experienced by participants in the study. Swelling was measured in millimeters using a ruler. Thus the distance of the ear tragus with The lower lip angle was measured before surgery and was considered as a reference for cheek swelling. Then this interval was measured on days 1, 2 and 3 after the operation and its difference with this interval before the operation was considered as a criterion for examining the swelling and thus the amount of swelling was obtained. Inflation rateIt was measured by the researcher in charge of filling out the questionnaire and information forms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Control group: Participants in the study were given 500 mg of mefenamic acid and 500mg of amoxicicillin after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Surgery, School of Dentistry, Islamic Azad University of Tehran
Full name of responsible person
Mohammad anvari digeh sara
Street address
Pasdaran Ave،neyestan 9th،Tehran Azad Dental School
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
s.alirezaei@iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
arash azizi
Street address
Pasdaran Ave،neyestan 9th،Tehran Azad Dental School
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drarashazizi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Mohammad anvari digeh sara
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Pasdaran Ave،neyestan 9th،Tehran Azad Dental School
City
Tehran
Province
Tehran
Postal code
5331419468
Phone
+98 21 2256 4571
Email
S.alirezaei@iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad anvari digeh sara
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Pasdaran Ave،neyestan 9th،Tehran azad dental school
City
Tehran
Province
Tehran
Postal code
5331419468
Phone
+98 21 2256 4571
Email
S.alirezaei@iautmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad anvari digeh sara
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Pasdaran Ave،neyestan 9th،tehran azad dental school
City
Tehran
Province
Tehran
Postal code
5331419468
Phone
+98 21 2256 4571
Email
S.alirezaei@iautmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available