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Effects of adjunctive use of 2% atorvastatin dentifrice plus vitamin C in treatment of chronic periodontitis

Protocol summary

Study aim
To determine the effectiveness of using atorvastatin 2% toothpaste with vitamin C as a supplement in the non surgical periodontal treatment of chronic periodontitis patients
Design
In this double-blind study, 72 patients with moderate to severe chronic periodontitis referring to periodontics department of Shahid Sadoughi Dental School of Yazd will be selected and after coding will be randomly divided into four intervention and control groups.
Settings and conduct
Initially, the levels of Modified Gingival Index (MGI), Bleeding on probing (BOP),Clinical Attachment Loss(CAL) and Probing Depth(PD) will be recorded for patients and after non-surgical periodontal treatment and receiving toothpaste and oral vitamin C in intervention groups for 4 weeks, patients will be recalled and the levels of PD, CAL, MGI and BOP will be re-evaluated.
Participants/Inclusion and exclusion criteria
inclusion criteria are the age between 30 to 60 years and the moderate to severe chronic periodontitis. exclusion criteria includes pregnancy, breast feeding, smoking, using immunosuppressive medications and NSAIDs and antibiotics and vitamin supplements and mouthwash, Autoimmune diseases, uncontrolled diabetes and Hyperlipidemia disease.
Intervention groups
non-surgical periodontal treatment will be done for all the patients and The control group will use 0.2% flouride toothpaste as an adjunct treatment, Group II: as an adjunct treatment, use toothpaste containing 0.2% fluoride and atorvastatin 2%.Group III: as an adjunct treatment, using 0.2% flouride toothpaste along with chewable tablets 250 mg of vitamin C. Group IV: as an adjunct treatment use toothpaste containing 0.2% fluoride and atorvastatin 2% with chewable tablets 250 mg of vitamin C.
Main outcome variables
Clinical variables are Probing depth, clinical attachment loss, , bleeding on probing and Modified gingival index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171015036782N5
Registration date: 2018-09-26, 1397/07/04
Registration timing: registered_while_recruiting

Last update: 2018-09-26, 1397/07/04
Update count: 0
Registration date
2018-09-26, 1397/07/04
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
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of adjunctive use of 2% atorvastatin dentifrice plus vitamin C in treatment of chronic periodontitis
Public title
Effects of adjunctive use of 2% atorvastatin dentifrice plus vitamin C in treatment of teeth supporting tissues disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 30 to 60 years old chronic moderate to severe periodontitis
Exclusion criteria:
Pregnancy Breast feeding Smoking Using immunosuppressive medications Using NSAIDs Using antibiotics over the past 3 months Using a vitamin supplement or mouthwash Having an autoimmune disease Uncontrolled diabetes Hyperlipidemia disease Special diet
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into four groups (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
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Approval date
2018-07-31, 1397/05/09
Ethics committee reference number
IR.SSU.REC.1397.061

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
Modified Gingival Index
Timepoint
Beggining of study and 1 month later
Method of measurement
by observation of the amount of inflammation in the mouth and then calibrate it

4

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

Secondary outcomes

empty

Intervention groups

1

Description
Control group: non-surgical periodontal treatment and daily administeration of 0.2% fluoride toothpaste for 4 weeks
Category
Placebo

2

Description
Intervention group: non-surgical periodontal treatment and daily prescription of toothpaste that contains atorvastatin 2% and 0.2% fluoride for 4 weeks
Category
Treatment - Drugs

3

Description
Intervention group: non-surgical periodontal treatment and daily prescription of 0.2% fluoride toothpaste and Chewable tablets of vitamin C with dose of 250 mg for 4 weeks
Category
Treatment - Drugs

4

Description
Intervention group: non-surgical periodontal treatment and daily prescription of toothpaste that contains atorvastatin 2% and 0.2% fluoride plus Chewable tablets of vitamin C with dose of 250 mg for 4 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amirhosein Vatandoust
Street address
Shahid Sadoughi Faculty of Dentistry Yazd, Emam Reza square
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
amirhosein.vatandoust@yahoo.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, Emam Reza Square
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
amirhosein.vatandoust@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Amirhosein Vatandoust
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
amirhosein.vatandoust@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amirhosein Vatandoust
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
amirhosein.vatandoust@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amirhosein Vatandoust
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
amirhosein.vatandoust@yahoo.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
amirhosein vatandoust, 09121713074, amirhosein.vatandoust@yahoo.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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