Protocol summary

Summary
The present study is used to evaluate the plaque removal efficacy of dentifrice alone during the manual tooth brushing.The study population consisted of 30 student volunteers of dental school of Isfahan medical university. inclusion criteria: age>18 years and at least 5 evaluable teeth per quadrant. Exclusion criteria are: orthodontic appliances,removable denture, pregnancy, smoking, periodontitis, any systemic disease that may effect the oral condition and hypersensitivity to the components of the dentifrices. Study design: in a double blinded cross over study 30 subjects, after 48 hours plaque accumulation have brushed randomly with one of the four study methods (brushing with one of the 3 dentifrices that differs with respect to the relative dentin abrasivity(RDA) and without dentifrice), under supervision for 2 minutes. Study was applied in 4 sessions and each subject experienced brushing with all of the methods at the end of the 4th session. Difference in plaque score before and after tooth brushing constitute the plaque reduction. Plaque scores was assessed according to the Quigly and Hein index( Turskey and Loben modification) and they were recorded, analyzed and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102234877N3
Registration date: 2011-09-04, 1390/06/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-09-04, 1390/06/13
Registrant information
Name
Jaber Yaghini
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 1434 2136
Email address
j_yaghini@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative evaluation of plaque control fallowing tooth brushing with three different dentifrices and wthout dentifrice
Public title
comparison of efficacy of tooth brushing with three different dentifrices and wthout dentifrice in plaque removal.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age>18 years and at least 5 evaluable teeth per quadrant; Exclusion criteria: orthodontic appliances; removable denture; pregnancy; smoking; periodontitis; any systemic disease that may effect the oral condition; hypersensitivity to the components of the dentifrices;
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan medical university
Street address
Periodontology department-Dental faculty-Isfahan medical university-Hezar jerib avenue-
City
Isfahan
Postal code
81746 -73461
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
390148

Health conditions studied

1

Description of health condition studied
dental plaque
ICD-10 code
K03.6
ICD-10 code description
Deposits [accretions] on teeth

Primary outcomes

1

Description
Dental plaque
Timepoint
Before brushing and after brushing
Method of measurement
Disclosing tab

Secondary outcomes

empty

Intervention groups

1

Description
In the third session, the first step is type 3; ORIGINAL SENSODINE to all of the volenteers and ask them to brush with the new toothbrush and toothpaste for a week in orther to be familiar to them. Then ask them not to use any kind of plaque control method for 48 hours. The next step is mesuring of plaque and then ask them to brush with their new tooth brush and tooth paste for 2 minutes.In the next step, examiner mesures the post brushing plaque and amount of plaque reduction and record it.
Category
Prevention

2

Description
The last session is asking volenteers not to use any kind of plaque control method for 48 hours. Then mesuring of plaque and then ask them to brush with their new tooth brush and without any toothpaste for 2 minutes.In the next step, examiner mesures the post brushing plaque and amount of plaque reduction and record it.
Category
Prevention

3

Description
The first step is giving the same toothbrush (gum 411) and toothpaste type 1; WHITENING POONE to all of the volenteers and ask them to brush with the new toothbrush and toothpaste for a week in orther to be familiar to them. Then ask them not to use any kind of plaque control method for 48 hours. The next step is mesuring of plaque and then ask them to brush with their new tooth brush and tooth paste for 2 minutes.In the next step, examiner mesures the post brushing plaque and amount of plaque reduction and record it.
Category
Prevention

4

Description
In the next session, first step is giving the toothpaste type2; 3DWHITE CREST to all of the volenteers and ask them to brush with the new toothbrush and toothpaste for a week in orther to be familiar to them. Then ask them not to use any kind of plaque control method for 48 hours. The next step is mesuring of plaque and then ask them to brush with their new tooth brush and tooth paste for 2 minutes.In the next step, examiner mesures the post brushing plaque and amount of plaque reduction and record it.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Dr jaber yaghini
Street address
Periodontology department, Dental faculty, Isfahan University of Medical Sciences
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Omid Savabi
Street address
Periodontology Department,Dental Faculty,Isfahan University of Medical Sciences
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant professor
Other areas of specialty/work
Street address
Periodontology department, Dental faculty,Isfahan University of Medical Sciences
City
Isfahan
Postal code
81746-73461
Phone
+98 31 1434 2136
Fax
+98 31 1668 7080
Email
j_yaghini@dnt.mui.ac.ir
Web page address
www.dnt.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant professor
Other areas of specialty/work
Street address
Periodontology department-Dental faculty-Isfahan medical university-Hezar jerib avenue-
City
Isfahan
Postal code
81746-73461
Phone
+98 31 1434 2136
Fax
+98 31 1668 7080
Email
j_yaghini@dnt.mui.ac.ir
Web page address
www.dnt.mui.ac.ir

Person responsible for updating data

Contact

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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