Evaluation of the effect of Curcumin on pain after periodontal flap surgery in comparison with the control group
Design
Double-blind clinical trial with split mouth design in which each sample participates in 2 phases, once as a case (consumption of Curcumin) and the next time as a control (consumption of Gelofen). (Based on surgery on different quadrants of one jaw) And will be checked in the form of 2 blocks using Excell software. According to the results of the previous study (Maulina et al.), Using the Paired Means Power Analysis option of PASS11 software, considering α = 0.05 and β = 0.2, the standard deviation of the changes is 1.2 and the difference between the means is 1. 16 two-way samples were calculated for the study.
Settings and conduct
The appearance and color of gelofen and turmeric capsules are similar and both the operator and the patient are unaware. The first dose is taken 30 minutes before surgery and subsequent doses every 8 hours (for 1 day).Onset of pain with pain based on Numerical Rating Scale (between zero to 10) and after taking the first, second and third dose, the phone is measured and 7 days after the end of medication, the patient referred for surgery on the opposite side of the jaw and by moving the groups, The steps will be repeated exactly.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients requiring periodontal flap surgery and exclusion criteria include allergy to urcumin and Ibuprofen (Gelofen), history of gastrointestinal problems and gastritis, use of anticoagulants, biliary problems and kidney stones.
Intervention groups
Control(Quadrant) group: Two 200 mg gelofen capsules Case(Quadrant) group: Take two 80 mg turmeric capsules after surgery (every 8 hours) for 1 day.
Main outcome variables
Use of curcumin, pain, age, sex, quadrant and jaw under surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200929048883N1
Registration date:2020-10-18, 1399/07/27
Registration timing:registered_while_recruiting
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Hesam Hamidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2630 4508
Email address
hesamhamidi75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Curcumin on pain after periodontal flap surgery
Public title
Evaluation of the efficacy of Curcumin on pain after periodontal flap surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in need of periodontal flap surgery
No history of allergy to Amoxicillin, Curcumin and Ibuprofen (Gelofen)
No history of taking any antibiotics, anti-inflammatory and analgesic at least 7 days before surgery
No history of gastrointestinal problems and gastritis, use of anticoagulants, biliary problems, kidney stones and gallbladder
Exclusion criteria:
Allergy to Curcumin and Ibuprofen (Gelofen)
History of gastrointestinal problems and gastritis
Taking anticoagulants
Kidney failure
Bile problems
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
16
More than 1 sample in each individual
Number of samples in each individual:
2
Patients received Curcumin in the first surgery and then 14 days after the last dose of the drug patients will go for surgery on the opposite side of the same jaw and receive Gelofen.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The same appearance and color of Gelofen and Curcumin capsules to keep participants informed is considered in the study and The surgeon and the person evaluating the outcome are also not aware of the type of medication given.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق در پژوهشهای زیست پزشکی
Street address
No. 9, 9th Neystan,Pasdaran St
City
tehran
Province
Tehran
Postal code
1946853314
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.IAU.DENTAL.REC.1398.041
Health conditions studied
1
Description of health condition studied
Pain after periodontal flap surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain
Timepoint
8,16 and 24 hours after surgery
Method of measurement
Questioning the patient by Numerical Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After surgery, take two 80 mg Curcumin capsules of Sina Curcumin Company (Tehran, Iran) three times a day (every 8 hours) for 1 day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Islamic Azad University, Building No. 3, Department of Periodontics
Full name of responsible person
Hesam Hamidi
Street address
No. 9, 9th Neystan, Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2630 4508
Email
hesamhamidi75@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Research and Technology Department
Street address
No. 9, 9th Neystan, Pasdaran St.
City
tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
hesamhamidi75@gmail.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
1
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
Islamic Azad University
Full name of responsible person
Hesam Hamidi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neystan, Pasdaran St.
City
tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2630 4508
Email
hesamhamidi75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hesam Hamidi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neystan, Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2630 4508
Email
hesamhamidi75@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hesam Hamidi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neystan, Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2630 4508
Email
hesamhamidi75@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Your data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
It can only be used for reviewing and validating the results by journals after submitting them to the said journal
From where data/document is obtainable
Refer to the responsible author at the address and e-mail address mentioned in the article
What processes are involved for a request to access data/document
After reviewing the reasons for the request, the documents will be sent to them within a month.