Aim: Examine the effect of Classic Gum and Sensivital Gum toothbrushes on periodontal indexes among pregnant women attending private clinic in districts 2 and 22 in Tehran.
Design of study: Interventional, unlimited aging, single blind, without placebo, parallel, prevention, randomized
Inclusion criteria: Women in the second trimester of pregnancy, with no systemic diseases such as diabetes and high blood pressure without drugs and without history of high-risk pregnancy,gingival index of at least 1.5
Exclusion criteria: Violation of any of the above condition.
Sample size: 52 persons
Interventions of study: Classic Gum and Sensivital Gum toothbrushes
Time of intervention: Before intervention , 14 days and 28 days after intervention
Outcomes of study: Gingival index, plaque index and probing pocket depth
Bass method brushing with Complete Crest toothpaste for two minutes in the morning and night and use floss and mouthwash are not used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013123116019N1
Registration date:2014-08-07, 1393/05/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-08-07, 1393/05/16
Registrant information
Name
Elham Mostafa
Name of organization / entity
Dental school of Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
k-saebi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2014-08-11, 1393/05/20
Expected recruitment end date
2014-11-16, 1393/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examine the effect of Classic Gum and Sensivital Gum toothbrushes on periodontal indexes in pregnant women
Public title
Effects of two toothbrushes in pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Women in the second trimester of pregnancy, with no systemic diseases such as diabetes and high blood pressure without drugs and without history of high-risk pregnancy, gingival index of at least 1.5
Exclusion criteria: Violation of any of the above condition
Age
From 15 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Bass method brushing with Complete Crest toothpaste for two minutes in the morning and night and use floss and mouthwash are not used
Because of the parallelism, there is no difference between the intervention group and the control. In fact, there is no control group. Patient groups and have each group is given a toothbrush and manual toothbrushes are compared.
Referred for researchers.
Toothbrushes to give to patients is performed by someone other than the researcher and the researcher does not know which toothbrush is given to each patient.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Dental school of Islamic Azad University
Street address
No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
Postal code
19585/175
Approval date
2014-05-26, 1393/03/05
Ethics committee reference number
د/160/پ
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Gingival index
Timepoint
Before intervention, 14 days and 28 days after intervention
Method of measurement
Priodontal probe used to score each tooth
2
Description
Plaque index
Timepoint
Before intervention, 14 days and 28 days after intervention
Method of measurement
Dental explorer used to score each tooth
3
Description
Probing pocket depth
Timepoint
Before intervention, 14 days and 28 days after intervention
Method of measurement
Applications of periodontal probe in millimeters
Secondary outcomes
1
Description
Gingivitis
Timepoint
Before intervention, 14 days and 28 days after intervention
Method of measurement
The use of the dental explorer and periodontal probe
Intervention groups
1
Description
Classic Gum tooth
Country of manufacturer: Sunstar corporate America
Company importer: MGTD company in Iran
Application procedure: Bass method for two minutes morning and night
Category
Prevention
2
Description
Sensivital Gum tooth
Country of manufacturer: Sunstar corporate America
Company importer: MGTD company in Iran
Application procedure: Bass method for two minutes morning and night
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school of Islamic Azad University
Full name of responsible person
Elham Mostafa
Street address
No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, dental school of Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
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, dental school of Islamic Azad University
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 school of Islamic Azad University
Full name of responsible person
Khosro Saebi
Position
Associate Professor of Islamic Azad University
Other areas of specialty/work
Street address
No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
Postal code
19685/175
Phone
+98 21 2256 4571
Fax
+98 21 2276 3450
Email
emhoot.12464@yahoo.com ; k_saebi@dentaliau.ac.ir
Web page address
reg.dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental school of Islamic Azad University
Full name of responsible person
Elham Mostafa
Position
Senior dental student
Other areas of specialty/work
Street address
No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
Postal code
19585/175
Phone
+98 21 2256 4571
Fax
+98 21 2276 3450
Email
emhoot.12464@yahoo.com ; k_saebi@dentaliau.ac.ir
Web page address
reg.dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dental school of Islamic Azad University
Full name of responsible person
Elham Mostafa
Position
Senior dental student
Other areas of specialty/work
Street address
No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
Postal code
19585/175
Phone
+98 21 2256 4571
Fax
+98 21 2276 3450
Email
emhoot.12464@yahoo.com ; k_saebi@dentaliau.ac.ir
Web page address
reg.dentaliau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)