Determining the effect of omega-3 supplement on the recovery of patients with periodontitis
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 44 patients.
Settings and conduct
Patients with chronic periodontitis referred to the periodontology department of the School of Dentistry of Shahid Sadoughi University of Medical Sciences, Yazd, after examination and inclusion criteria, are examined and randomly divided into two groups of intervention and control.In addition to the usual non-surgical treatment of periodontitis(scaling and root planning with ultrasonic devices), daily consumption of one omega-3 soft gel for 3 months in case group and daily use of a soft gel containing placebo for 3 months in control group.The drug consultant will distribute the drug to the groups and the patient and the researcher are not aware of any of the drugs received (placebo or omega 3).
Participants/Inclusion and exclusion criteria
Patients with severe periodontitis who do not have systemic disease or conditions that interfere with periodontal status.
Intervention groups
Intervention group: In addition to the usual non-surgical treatment of periodontitis(scaling and root planning with ultrasonic devices), daily consumption of one omega-3 soft gel for 3 months
Control group: In addition to the usual non-surgical treatment of periodontitis(scaling and root planning with ultrasonic devices), daily use of a soft gel containing placebo for 3 months
Main outcome variables
periodontal pocket depth, clinical attachment loss, bleeding index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151013024509N5
Registration date:2021-07-17, 1400/04/26
Registration timing:registered_while_recruiting
Last update:2021-07-17, 1400/04/26
Update count:0
Registration date
2021-07-17, 1400/04/26
Registrant information
Name
Fahimeh Rashidi Maybodi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 519 6227
Email address
f-rashidi63@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the adjunctive use of omega3 fatty acids in periodontal parameters
Public title
Evaluation of the adjunctive use of omega3 fatty acids in gingival diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age should be between 30-60 years
clinical attachment loss should be greater than 3 mm.
The patient should be healthy.
Exclusion criteria:
smoking
history of periodontal treatment in last 6 months
presence any disease or systemic conditions that have interfered with wound healing.
inflammatory conditions in the oral cavity
use the medicines affect periodontium .
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into control and intervention groups using simple random allocation method and random number table. the total sample size is 44 people who were randomly divided into two groups of 22 people and a random table was provided to the researcher and based on it. The control and intervention group is determined. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process and will not have the authority to change or predict the status of individuals.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications are coded by the consulting pharmacist and the examiner and patient will not know the type.omega3 soft gel and its placebo is completely similar.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
•Ethics committee of shahid sadooghi Yazd University of Medical Sciences
Street address
imam reza bulvar,School of Dentistry, University of Medical Sciences, Yazd
City
yazd
Province
Yazd
Postal code
894815667
Approval date
2021-05-10, 1400/02/20
Ethics committee reference number
IR.SSU.REC.1400.025
Health conditions studied
1
Description of health condition studied
periodontitis
ICD-10 code
K05.32
ICD-10 code description
Chronic periodontitis, generalized
Primary outcomes
1
Description
chronic periodontitis
Timepoint
initial examination-1 and 3 months after using omega3
Method of measurement
evaluation of clinical periodtal parameters
Secondary outcomes
1
Description
periodontal pocket depth
Timepoint
initial examination, 1and 3 months after consumption OMEGA3
Method of measurement
measurement by periodontal probe
2
Description
clinical attachment loss
Timepoint
initial examination, 1and 3 months after consumption OMEGA3
Method of measurement
measurement by periodontalprobe
3
Description
bleeding index
Timepoint
initial examination, 1and 3 months after consumption OMEGA3
Method of measurement
Percentage of bleeding areas(6 areas around the tooth)
Intervention groups
1
Description
Intervention group: After the usual non-surgical treatment of chronic periodontitis (scaling akd root planing , the intervention group will take the 1000mg omega 3 soft gel supplement, manufactured by Yas Daroo Meybod Company for 3 months. The variables will be checked again after 1 and 3 months.
Category
Treatment - Drugs
2
Description
Control group: After the usual non-surgical treatment of chronic periodontitis (scaling akd root planing with ultrasonic devices) , this group will take placebo soft gel, manufactured by Yas Daroo Meybod Company for 3 months. The variables will be checked again after 1 and 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
periodontology department , yazd dental school
Full name of responsible person
Mahsa Fakhari
Street address
Imam Reza Boulevard,Yazd dental school
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5880
Email
m.fakhari2012@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hassan Mozaffari
Street address
Shahid bahonar square
City
yazd
Province
Yazd
Postal code
8916844933
Phone
+98 35 1725 8413
Email
mozaffari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mahsa Fakhari
Position
post graduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Imam Reza Boulevard,yazd dental school
City
yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5880
Email
m.fakhari2012@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahsa Fakhari
Position
post graduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Imam Reza Boulevard, yazd dental school
City
yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5880
Email
m.fakhari2012@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farhad Fatehi
Position
Responsible for International Relations
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
ImamReza boulevard,yazd dental school
City
yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5880
Email
ffatehi@gmail.com
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