In this double-blind randomized clinical trial study 60 patients referring to Period-ontology Department of Dental Clinic of Babol University are selected on the basis of inclusion criteria (suffering from plaque induced chronic gingivitis, etc) and exclusion criteria (smoking, etc). Patients are randomly divided to two groups of 30. After coding bottles of mouth-rinse will be given to each patient by a nurse who is not aware of mouth-rinse type in the bottles. The intervention group will be given mouth-rinse containing VI-ONE chlorhexidine (0.2%chlorhexidine type and alcohol free/ manufactured by Rojin Chemicals) and the control group will be given mouth-rinse containing 0.2% chlorhexidine (manufacturer: Pharmacy BEHSA). Primary outcomes will include: Plaque Index (PI); Stain Index (SI); Gingival Index (GI); Bleeding Index (BI). These variables will be measured during the first day of study and two weeks after the study starts in Ram fjord teeth of both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602231760N45
Registration date:2016-03-05, 1394/12/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-05, 1394/12/15
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Babol University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical evaluation of Vi-one chlorhexidine mouthrinse on plaque induced gingivitis
Public title
The clinical evaluation of Vi-one chlorhexidine mouthrinse on plaque induced gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the patient's age, 25 to 50 years; chronic gingivitis patients with moderate - severe associated with dental plaque; patients with the ability to cooperate and has a similar plaque index.
Exclusion criteria:
patients with a history of systemic diseases affecting the periodontal; smoking; patients with any periodontal treatment during the last 6 months; patients treated with antibiotics in the past month.
Age
From 25 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is double-blind clinical trial.
Sampler and the patient, do not know the type and content of mouthwash bottles.
The two groups are matched by age.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenu
City
Babol
Postal code
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
MUBABOl.REC.1394.188
Health conditions studied
1
Description of health condition studied
Chronic gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Plaque induced
Timepoint
The first day of the study and two weeks after the start of the study
Method of measurement
Plaque Index (PI), based on the Silness and Loe's method
2
Description
Plaque Index
Timepoint
The first day of the study and two weeks after the start of the study
Method of measurement
Plaque Index (PI) based on Silness and Loe's method
3
Description
Gingival index
Timepoint
The first day of the study and two weeks after the start of the study
Method of measurement
Gingival index (GI) based on the method of Loe and Silness
4
Description
Gingival bleeding index
Timepoint
The first day of the study and two weeks after the start of the study
Method of measurement
Gingival bleeding index (Bleeding Index (BI) (Bernet
Secondary outcomes
empty
Intervention groups
1
Description
Intervention groups:
Patients are requested to use VI-ONE mouthrinse for 30 seconds (0.2%chlorhexidine type and alcohol free/ manufactured by Rojin Chemicals) twice a day, once in the morning and once at night after brushing their teeth. They are asked not to wash their mouth and not to eat for 2 hours as far as possible and they should retain this for 2 weeks.
Category
Treatment - Drugs
2
Description
Control groups:
Methods such as the intervention group. The difference is that the patients mouthwash containing Chlorhexidine 0.2% (manufacturer: Pharmacy BEHSA) is given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental colleges of Babol
Full name of responsible person
Marzyeh Omidbakhsh
Street address
Dental College, Babol University of Medical Sciences, Ganjafrooz Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Ganjafrooz Avenue, Babol University of Medical sciences Babol
City
Babol
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, Babol 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
Dental College of Babol
Full name of responsible person
Marzyeh Omidbakhsh
Position
Dental students
Other areas of specialty/work
Street address
Dental College, Babol University of Medical Sciences, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 3229 1408
Fax
Email
marzyehomidbakhsh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental College of Babol
Full name of responsible person
Dr. Babak Amoian
Position
Professor of Periodontology
Other areas of specialty/work
Street address
Dental College, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
+98 11 3229 1408
Fax
Email
amoian@perio.org
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
Other areas of specialty/work
Street address
Babol University of Medical sciences, Ganjafrooz Avenue
City
Babol
Postal code
Phone
00
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)