Evaluation the effect of Vitamin E supplements on chronic periodontitis
Design
Randomized clinical trial with parallel group
Settings and conduct
16 patients with chronic periodontitis referred to Isfahan Dental School were selected and according to the order of inclusion in the study, they were divided into case and control groups, respectively.The indices of pocket depth and attachment loss for 6 teeth per person were measured with a periodontal probe. A total of 42 teeth in case and 41 teeth in control group were examined. Then, 2 ml nonstimulated saliva was collected from each patient for measuring total antioxidant capacity (TAC). All patients were treated with scaling and root planing and for the case group, vitamin E 200 IU was given daily for 2 months . The case group consumed 200 IU supplementary Vitamin E daily for up to 2 months. After 2 months, clinical indexes were re‑measured and 2 ml nonstimulated saliva was collected for measuring TAC.
Participants/Inclusion and exclusion criteria
Patients with generalized chronic mild to moderate periodontitis. The exclusion criteria include patients with systemic disease or unwillingness to continue the study
Intervention groups
First scaling was down for all patients in two groups. A baseline visit was performed after 2 weeks for controlling oral hygiene and any residual calculus and case group received 200 IU supplementary Vitamin E to consume daily up to 2 months.
Main outcome variables
pocket depth؛ clinical attachment level؛ total antioxidant capacity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110109005570N10
Registration date:2021-07-21, 1400/04/30
Registration timing:retrospective
Last update:2021-07-21, 1400/04/30
Update count:0
Registration date
2021-07-21, 1400/04/30
Registrant information
Name
Parichehr Behfarnia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1666 1707
Email address
behfarnia@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of vitamin E supplementation in the treatment of patients with chronic periodontitis
Public title
Evaluation of the effect of vitamin E in chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with generalized chronic mild to moderate periodontitis and clinical attachment loss between 1 and 5 mm
Exclusion criteria:
patients with systemic disease or unwillingness to continue the study
Age
From 25 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
More than 1 sample in each individual
Number of samples in each individual:
6
6 teeth are examined in each patient
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-02-14, 1397/11/25
Ethics committee reference number
IR.MUI.REC.1396.3.173
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Pocket depth
Timepoint
At the beginning of the study (before the intervention) and 2 months after scaling and taking vitamin E capsules
Method of measurement
by periodontal probe
2
Description
clinical attachment level
Timepoint
At the beginning of the study (before the intervention) and 2 months after scaling and taking vitamin E capsules
Method of measurement
by periodontal probe
3
Description
Total anti oxidant capacity of saliva
Timepoint
At the beginning of the study (before the intervention) and 2 months after scaling and taking vitamin E capsules
Method of measurement
by Zellbio’s TAC Kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Scaling and root planing with ultrasonic device(cavitron), Prescribe 200 units of vitamin E capsules once a day for two months.
Category
Treatment - Other
2
Description
Control group: Scaling and root planing with ultrasonic device(cavitron)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school, Isfahan University of Medical Science
Full name of responsible person
Parichehr Behfarnia
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
Dr.pbehfarnia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nakisa Torabinia
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5524
Email
torabinia@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar garib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5559
Email
Dr.pbehfarnia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5559
Email
Dr.pbehfarnia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5559
Email
Dr.pbehfarnia@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 can be shared
When the data will become available and for how long
Start of access one year after data printing
To whom data/document is available
It will be available to all researchers
Under which criteria data/document could be used
The use of the obtained data for systematic review is allowed
From where data/document is obtainable
Dr.pbehfarnia@gmail.com
What processes are involved for a request to access data/document