Protocol summary

Summary
The purpose of this study is to evaluate the effect of sequence order of brushing and flossing on periodontal indices.This cross-over clinical trial is conducted on 35 students recruited from dental school, Hamedan University of Medical sciences. Inclusion criteria: having healthy gingiva and last grad dentistry student. Exclusion criteria: no systemic disease; no gingivitis and periodontist and no use of orthodontic appliance. The subjects will ask to brush then using dental floss for a 2-week period and use dental floss then brushing for another 2-week period. The subjects practice dental hygiene according to their habitual method for a 7-day washout interval between two periods. The individuals will receive scaling and professional brushing in the beginning and undergoing PCI, PI and BOP measurement at the end of each period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012071710304N1
Registration date: 2012-08-06, 1391/05/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-08-06, 1391/05/16
Registrant information
Name
Davood Mansoori
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1074
Email address
sr.arabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of sequences of flossing and brushing on periodontal indices.
Public title
Effects of sequence of flossing and brushing on periodontal indices.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having healthy gingiva and last grad dentistry student. Exclusion criteria: no systemic disease; no gingivitis and periodontist and no use of orthodontic appliance.
Age
From 23 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences Ethics Committee
Street address
Mahdiyeh street, PZhoohesh four way, in front of Mardom park, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Approval date
2012-04-22, 1391/02/03
Ethics committee reference number
16/35/9/240/پ/د

Health conditions studied

1

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

Primary outcomes

1

Description
plaque index
Timepoint
two weeks
Method of measurement
given disclosing tabs to subjects and account of coulered teeth surfaces

2

Description
plaque control record
Timepoint
two week
Method of measurement
given disclosing tablets to subjects and acount of coulered teeth sourfaces.

3

Description
bleeding on probing
Timepoint
two weeek
Method of measurement
using of probing of gingival salcus and measurment of bleeding points.

Secondary outcomes

empty

Intervention groups

1

Description
the correct way of Flossing and brushing will educated to all of subjects. and same brush, floss and toothpaste will give to them.The individuals will receive scaling and professional brushing in the beginning. The subjects were asked to brush then using dental floss for a 2-week period and use dental floss then brushing for another 2-week period. The subjects practiced dental hygiene according to their habitual method for a 7-day washout interval between two periods. there is only one group in this study and each person compares with itself.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Periodontologhy department, Hamedan faculty of dentistry
Full name of responsible person
Street address
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Hamedan University of Medical Sciences
Full name of responsible person
Haidar Tavilani
Street address
Mahdiyeh street, In front of Mardom park, Hamedan University of Medical Sciences
City
Hamedan
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, Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Parviz torkzaban
Position
PhD
Other areas of specialty/work
Street address
Mahdiye street, in ftont of Mardom park, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1838 1081
Fax
Email
torkzaban@umsha.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Parviz Torkzaban
Position
PhD
Other areas of specialty/work
Street address
Mahdiyeh street, Pezhoohesh four way, in front of Mardom park.
City
Hamedan
Postal code
Phone
+98 81 1838 1081
Fax
Email
torkzaban@umsha.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Marieh Rashidi
Position
Student of dentistry
Other areas of specialty/work
Street address
Mahdiye street, in ftont of Mardom park, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
Fax
Email
mlaria_solaris@yahoo.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
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