Protocol summary

Summary
The overall objective of this study was to compare the effects of a mouthwash with chlorhexidine 2.0% General's bathtub on periodontal index in patients with chronic periodontitis is the pocket of 3-6 mm.Randomized, double-blind, placebo-controlled. The main inclusion criteria to ensure the chronicity and the envelope is 3.6 mm. The main criterion of the absence of envelope Khzvj is 3-6 mm. In this study, 30 patients (a total of 180 periodontal pockets) ages 30 years and older by referring to the section of Periodontology, School of Dentistry, Yazd martyr chosen based on inclusion criteria and indicators to evaluate the pocket depth, clinical attachment level indicator, bleeding index, plaque index, respectively. Intervention in this study is the use of mouthwash. Intervention time is 4 weeks. Scaling is performed for patients. Health education at the same time for all patients is explained. Patients of mouthwash twice a day, and in the meantime not to use any medication or other mouthwash.Four weeks after patients called mouthwash and indicators will be logged. 3.6 mm stage surgical procedures used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015092724232N1
Registration date: 2015-10-22, 1394/07/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-22, 1394/07/30
Registrant information
Name
Shahab Shahhosseini
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 9686
Email address
d-za80@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2015-01-25, 1393/11/05
Expected recruitment end date
2015-04-23, 1394/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of General Vi-one mouthwash with Chlorhexidine 0.2 % on periodontal parameters in patients with chronic periodontitis.
Public title
Comparison of General Vi-one mouthwash with Chlorhexidine 0.2 %
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ensuring the chronicity; there are pockets of 3-6 mm; absence of systemic diseases and pregnancy; lack of prior therapy or surgery in the absence of smoking; alcohol and antibiotics and drugs interfering with oral protests in the past 6 months and ultimately ensure patient cooperation.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd University of Medical Sciences
Street address
Yazd- Bahonar
City
yazd
Postal code
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
223658/1/17/پ

Health conditions studied

1

Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.6
ICD-10 code description
Periodontal disease, unspecified

Primary outcomes

1

Description
Probing Pocket Dept
Timepoint
Before and four weeks after intervention
Method of measurement
mm with the probe

2

Description
Clinical Attachment Level
Timepoint
Before and four weeks after intervention
Method of measurement
mm with the probe

3

Description
Bleeding Index
Timepoint
Before the experiment, four weeks after the intervention
Method of measurement
The percentage of points

4

Description
Plaque Index
Timepoint
Before the experiment, four weeks after the intervention
Method of measurement
Percent of levels

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group after scaling and Brvsazh and health education, mouthwash is determined to use it twice a day for four weeks
Category
Prevention

2

Description
In the control group after scaling and Brvsazh and health education, mouthwash is determined to use it twice a day for four weeks
Category
Prevention

3

Description
After scaling and Brvsazh and health education control group, placebo-controlled study is to use it twice a day for four weeks
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry, Yazd
Full name of responsible person
Street address
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mozaffari
Street address
Yazd University of Medical Sciencesm Bahonar blvd.
City
Yazd
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
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
Yazd University of Medical Sciences
Full name of responsible person
Shahab Shahhosseini
Position
Dental students
Other areas of specialty/work
Street address
Faculty of Dentistry, Yazd University of Medical Sciences
City
Yazd
Postal code
Phone
+98 35 3724 9333
Fax
Email
shahabkorg.8870@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shahab Shahhosseini
Position
Dental students
Other areas of specialty/work
Street address
Faculty of Dentistry, Yazd University of Medical Sciences
City
Yazd
Postal code
Phone
+98 35 3724 9333
Fax
Email
shahabkorg.8870@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
shahab shahhosseini
Position
Dental students
Other areas of specialty/work
Street address
Faculty of Dentistry, Yazd University of Medical Sciences
City
Yazd
Postal code
Phone
+98 35 3724 9333
Fax
Email
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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