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Comparing the effect of Resveratrol supplementation and standard treatment on clinical parameters and inflammatory markers in the patients with chronic periodontitis

Protocol summary

Study aim
Determine the therapeutic effect of resveratrol (as adjunct therapy) on clinical parameters and inflammatory markers of saliva among chronic periodontitis patients
Design
In this double-blind study, 40 patients with moderate to severe chronic periodontitis referring to periodontics department of Shahid Sadoughi Dental School of Yazd were selected and after coding were randomly divided into intervention and control groups.
Settings and conduct
Initially, the levels of Plaque Index(PI), Clinical Attachment Loss(CAL), Probing Depth(PD), Bleeding Index(BI) and IL-8 and IL-1β in saliva will be recorded for patients and after non-surgical periodontal treatment and receiving capsules in both groups for 4 weeks, patients will be recalled and the levels of PD, CAL, PI, BI, and the levels of IL-8 and IL-1β in saliva will be re-evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 30 to 60 years; moderate to severe chronic periodontitis. Exclusion criteria: pregnancy, breast feeding, smoking, using immunosuppressive medications and NSAIDs, using medications that slow blood clotting; cancer under treatment
Intervention groups
non-surgical periodontal treatment will be done for all the patients.The patients in intervention group will take 480 mg resveratrol capsule daily and the control patients will take 480mg placebo capsules containing starch daily.
Main outcome variables
Clinical variables: Probing depth, clinical attachment loss, plaque index, bleeding index, The levels of IL-8 and IL-1β in saliva

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171015036782N6
Registration date: 2018-10-07, 1397/07/15
Registration timing: registered_while_recruiting

Last update: 2018-10-07, 1397/07/15
Update count: 0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
farzane vaziri
Name of organization / entity
Shahid sadoughi dental university
Country
Iran (Islamic Republic of)
Phone
+98 35 3620 4764
Email address
f.vaziri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Resveratrol supplementation and standard treatment on clinical parameters and inflammatory markers in the patients with chronic periodontitis
Public title
Effect of herbal medicine, Resveratrol, on gingival infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 30 to 60 years old chronic moderate to severe periodontitis
Exclusion criteria:
Pregnancy Breast feeding Traveling for more than 2 weeks Smoking Using immunosuppressive medications Using NSAIDs Using anti hypertension drugs or Medications that slow blood clotting such as warfarin Using insulin Affecting by uterine cancer, breast cancer or ovarian cancer or being under cancer treatment Advanced kidney and liver problems Allergy to black grapes or blueberry Periodontal treatment history during the past 6 months Considerable changes in diet over the past 6 months
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into control and intervention groups using a random-number table
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants and the investigator will not be aware of the type of prescribed drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
P4, Yas complex, Javadolaeme, Safayieh
City
Yazd
Province
Yazd
Postal code
8915839985
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.SSU.REC.1396.206

Health conditions studied

1

Description of health condition studied
moderate to severe chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

Primary outcomes

1

Description
Probing depth
Timepoint
Beggining of study and 1 month later
Method of measurement
Williams probe

2

Description
Clinical Attachment Loss
Timepoint
Beggining of study and 1 month later
Method of measurement
Using the Williams probe

3

Description
Plaque Index
Timepoint
Beggining of study and 1 month later
Method of measurement
By colloring with disclosing pills and calculating the percentage of whole mouth

4

Description
Bleeding Index
Timepoint
Beggining of study and 1 month later
Method of measurement
Checking Bleeding on probing in the mouth and measuring its percentage

5

Description
The level of IL-8 in saliva
Timepoint
Beggining of study and 1 month later
Method of measurement
Eliza kit

6

Description
The level of IL-1β in saliva
Timepoint
Beggining of study and 1 month later
Method of measurement
Eliza kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Non-surgical periodontal treatment and daily administration of resveratrol 480 mg capsule, produced by Herbafit company (Germany) for 4 weeks
Category
Treatment - Drugs

2

Description
Control group: non-surgical periodontal treatment and daily administeration of placebo 480 mg capsule (containing starch) for 4 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shabnam Nikniaz
Street address
Shahid Sadoughi Faculty of Dentistry Yazd, Emam Reza square
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
sh.nikniaz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alireza Danesh Kazemi
Street address
Shahid Sadoughi Faculty of Dentistry Yazd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
sh.nikniaz@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
Shabnam Nikniaz
Position
Post graduation student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
P4, Yas complex, Javadolaeme, Safayieh
City
Yazd
Province
Yazd
Postal code
8915873948
Phone
+98 914 490 1929
Email
sh.nikniaz@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shabnam Nikniaz
Position
Post graduation student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
P4, Yas complex, Javadolaeme, Safayieh
City
Yazd
Province
Yazd
Postal code
8915873948
Phone
+98 914 490 1929
Email
sh.nikniaz@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shabnam Nikniaz
Position
Post graduation student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
P4, Yas complex, Javadolaeme, Safayie
City
Yazd
Province
Yazd
Postal code
8915873948
Phone
+98 914 490 1929
Email
sh.nikniaz@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
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
Title and more details about the data/document
The whole data is shared
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Email, Call
From where data/document is obtainable
Shabnam Nikniaz, 09144901929, sh.nikniaz@gmail.com
What processes are involved for a request to access data/document
After sending the Email, the data will be transmitted
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