Protocol summary

Summary
The aim of present study is to evaluate the effects of Chlorhexidine (CHX) and Jaftex mouthwashes on periodontal indices. This study is designed as a double blind clinical trial including 20 healthy students Volunteer. The exclusion criteria will be participants with any systemic and periodontal disease. The students will be randomly divided into two groups. Group A: participants will receive CHX mouthwash; Group B: participants will take Jaftex mouthwash. Students will be asked to use 15cc of mouthwashes twice daily (every two minutes) for a period of two weeks. Students will be examined before taking the mouthwashes and two weeks later. And clinical periodontal indices including plaque index (The index O'leary), gingival index (Loe & Silness) and dental staining index (Stain index) will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050919698N3
Registration date: 2016-09-04, 1395/06/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Fatemeh Babadi
Name of organization / entity
Ahwaz jundi Shapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 5319
Email address
babadi-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundi Shapour University of Medical Sciences
Expected recruitment start date
2016-04-07, 1395/01/19
Expected recruitment end date
2016-08-09, 1395/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of chlorhexidine mouthwash with Jaftex in periodontal index in Dental students of Ahvaz University of Medical Sciences
Public title
Comparison of the effects of chlorhexidine mouthwash with Jaftex in periodontal index: A pilot study
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Health Persons exclusion criteria: the presence of systemic disease; smoking; periodontal disease; taking antibiotics; and other mouthwashes in the past three months.
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 20
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 Ahwaz Jundi Shapur University Of Medical Sciences
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
Postal code
Approval date
2015-02-07, 1393/11/18
Ethics committee reference number
ajums.REC.1393.415

Health conditions studied

1

Description of health condition studied
periodontal Condition
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases

Primary outcomes

1

Description
areas of staining
Timepoint
before and two after use
Method of measurement
All surfaces are divided into three parts. The total score is calculated for various levels divided by four

2

Description
Gingival Index
Timepoint
before and two after use
Method of measurement
loe & Silness index

3

Description
Plaque Index
Timepoint
before and two after use
Method of measurement
The O'Leay index

4

Description
Stain index Intensity
Timepoint
before and two after use
Method of measurement
Numerical scale. From zero to 3

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Groups: Jaftex, The mouthwash twice a day for two weeks
Category
Prevention

2

Description
Control group: Chlorhexidine, The mouthwash twice a day for two weeks
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahwaz Jundi Shapur University Of Medical Sciences School Of Dental Medicine
Full name of responsible person
Dr Fatemeh Babadi
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz Jundi Shapur University of Medical Sciences
Full name of responsible person
Dr Mohammad Mousavi
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
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, Ahwaz Jundi Shapur 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
Name of organization / entity
Ahwaz Jundi Shapur University of Medical Sciences
Full name of responsible person
Dr Fatemeh Babadi
Position
Asistant Professor Of Oral And Maxillofatioal Medicen
Other areas of specialty/work
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3320 5319
Fax
+98 61 3320 5168
Email
Fatemeh.babadi@yahoo.com, Fatemehbabadii@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz Jundi Shapur University of Medical Sciences
Full name of responsible person
Dr Fatemeh Babadi
Position
Specialist Oral And Maxillofatioal Disease
Other areas of specialty/work
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3320 5319
Fax
+98 61 3320 5168
Email
Fatemeh.babadi@yahoo.com, Fatemehbabadii@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz Jundi Shapur University of Medical Sciences
Full name of responsible person
Dr Fatemeh Babadi
Position
Asistant Professor Of Oral And Maxillofatioal Medicen
Other areas of specialty/work
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3320 5319
Fax
+98 61 3320 5168
Email
Fatemeh.babadi@yahoo.com, Fatemehbabadii@gmail.com
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
Loading...