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Phytochemical evaluation Scrophularia striata essential oils and clinical and anti¬bactrial effect of hydroalcholic extract of S. striata in chronic periodontitis disease

Protocol summary

Summary
Effect of hydroalcholic extract of S. striata mouth wash will be evaluated on chronic periodontitis in this study. Chronic periodontitis patients will enroll in this double blind study, they will randomly divide into two groups. Each group will consist of 25 patients. Hydroalcholic extract of S. striata and Irsha mouth wash will be used for each group.Plaque index, bleeding on probing and pocket depth will measure on base line, two weeks and one month after mouth wash usage.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015081323468N1
Registration date: 2015-09-08, 1394/06/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-08, 1394/06/17
Registrant information
Name
Nazli Rabienejad
Name of organization / entity
Hamadan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1059
Email address
n.rabinezhad@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2016-12-29, 1395/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Phytochemical evaluation Scrophularia striata essential oils and clinical and anti¬bactrial effect of hydroalcholic extract of S. striata in chronic periodontitis disease
Public title
Evaluation of Scrophularia striata essential oils effect in chronic periodontitis disease
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: chronic periodontitis exclusion criteria: systemic disease; pregnancy; smoking
Age
From 25 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Hamadan University of Medical Sciences
Street address
Mardom street, Hamadan
City
Hamadan
Postal code
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.UMSHA.REC.1394.243

Health conditions studied

1

Description of health condition studied
chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Periodontitis: NOS complex simplex

Primary outcomes

1

Description
plaque index
Timepoint
base line, two weeks, one month
Method of measurement
visual

2

Description
bleeding on probing
Timepoint
base line, two weeks, one month
Method of measurement
periodontal probe

3

Description
probing depth
Timepoint
base line, two weeks, one month
Method of measurement
periodontal probe

Secondary outcomes

1

Description
plaque index
Timepoint
two weeks, one month
Method of measurement
visual

2

Description
bleeding on probing
Timepoint
two weeks, one month
Method of measurement
periodontal probe

3

Description
probing depth
Timepoint
two weeks, one month
Method of measurement
periodontal probe

Intervention groups

1

Description
Scrophularia striata mouth wash twice a day for one month
Category
Treatment - Drugs

2

Description
Irsha mouth wash twice a day for one month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamadan Dental Faculty
Full name of responsible person
Nazli Rabienejad
Street address
Select
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Hamadan University of Medical Sciences
Full name of responsible person
Dr. Alikhani
Street address
Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dentistry Faculty
Full name of responsible person
Nazli Rabienejad
Position
Periodontics
Other areas of specialty/work
Street address
Periodontology department of Hamadan Dentistry Faculty
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
nazlirabi@yahoo.com; n.rabinezhad@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dentistry Faculty
Full name of responsible person
Nazli Rabienejad
Position
Assistant
Other areas of specialty/work
Street address
Periodontology department of Hamadan Dentistry Faculty
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
nazlirabi@yahoo.com; n.rabinezhad@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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