This study will be conducted as a clinical trial. The purpose of this study is investigation of toothbrush wear effect on its clearing power. Inclusion criteria:
1- not to use orthodontic brackets
2- not to use fixed partial dentures
3- not to use antibiotics or any mouthwashes
4- no need for surgery in the mouth during the study,
5- or not suffering from any systemic disease or any factor that can affect the accumulation of plaque on teeth and oral hygiene level.
6- only right handed people are chosen.
Exclusion criteria:
1- using of orthodontic brackets
2- using of antibiotics or any mouth washes
3- need for surgery in the mouth during the study
4- using of fixed partial dentures
5- suffering from any systemic disease or any factor that can affect the accumulation of plaque on teeth and oral hygiene level
6- Left handed people.
Twenty six subjects will be randomly selected from dental college students. At the beginning of the study subjects will be informed of the purpose, procedural aspects and the period of the study. All participants provided written, and informed consent after complete description of the study. Necessary will be given to them according the Bass technique. Each subject will be provided with a new toothbrush and tooth paste. They will be required to refrain from using any mouthwash or the things for cleaning the teeth during the study. Upon the completion of phase I treatment, we will measure plaque index, if necessary. Individuals will brush for 12 weeks two times per day. Subjects will be called after 6, 9 and 12 weeks for measuring plaque index and wear index. Dental plaque index will be measured and calculated by O'Leary technique. Wear index will be measured according to Rawls. Then the data will be analyzed by using SPSS-18 software, statistical tests ANOVA and Pearson correlation analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201094877N8
Registration date:2012-12-11, 1391/09/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-11, 1391/09/21
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
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-05-16, 1391/02/27
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of effect of toothbrush wear on plaque control in dental faculty students.
Public title
Effects of toothbrush wear on plaque control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1- not to use orthodontic brackets
2- not to use fixed partial dentures
3- not to use antibiotics or any mouthwashes
4- no need for surgery in the mouth during the study,
5- or not suffering from any systemic disease or any factor that can affect the accumulation of plaque on teeth and oral hygiene level.
6- only right handed people are chosen.
Exclusion criteria:
1- using of orthodontic brackets
2- using of antibiotics or any mouth washes
3- need for surgery in the mouth during the study
4- using of fixed partial dentures
5- suffering from any systemic disease or any factor that can affect the accumulation of plaque on teeth and oral hygiene level
6- Left handed people
Age
From 21 years old to 28 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics of Isfahan University of Medical Sciences
Street address
School of dentistry, Isfahan University of Medical Sciences. Hezar Jerib Street.
City
Isfahan
Postal code
73461-81746
Approval date
2012-06-14, 1391/03/25
Ethics committee reference number
10/536/د
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
k03.6 , k0
ICD-10 code description
Deposits [accretions] on teeth
Primary outcomes
1
Description
Plaque index
Timepoint
The beginning of study, Sixth Week, Ninth Week and Week Twelve.
Method of measurement
After using of the disclosing tablets, the plaque index will be calculated using the following equation: 100 × {(number of teeth × 4) / number of stained (non occlusal surfaces)}
Secondary outcomes
1
Description
Toothbrush wear
Timepoint
Sixth Week, Ninth Week, Twelfth Weeks
Method of measurement
All dimensions of brushes will be measured by digital caliper individually. Then brush wear index will be calculated using the following: WI = (FLL-BLL) + (FFL-BFL) / BRL WI, brush wear index FLL, Brystal length in the surface BLL, Brystal length at the base FFL, Brystal width in the surface BFL, Brystal width at the base BRL, the height of Brystl.
Intervention groups
1
Description
This study will be conducted in prospective interventional method. Twenty six participants are selected from dental students. We will use Butler toothbrush and oral disclosures which both of them are made in America, and Crest 7 toothpaste is made in Germany. Individuals will brush for 12 weeks two times a day. At the baseline and at 6, 9, 12 weeks plaque index will measured with O'Leary technique and with use of disclosure tablets. In 6, 9, 12 weeks Toothbrush wear index will measured with Rawls technique. In the Bass technique toothbrush is placed on the tooth with an angle of about 45 degrees. So brush strings penetrate to the gingival sulcus. Then will given short - range vibrating moves in the anterior – posterior toothbrush. In every area of the teeth, twenty moving is recommended. In the palatal and lingual maxillary and mandibular anterior teeth due to space constraints, the toothbrush put vertically and teeth are cleaned individually with tip. In occlusal surfaces, toothbrush placed horizontally and with low range of back - forward motions cleaning operation is carried
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School
Full name of responsible person
Saeid Poursaadat
Street address
School of dentistry, Isfahan University of Medical Sciences. Hezar Jerib Street.
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
Doctor Omid Savabi
Street address
School of dentistry, Isfahan University of Medical Sciences.Hezar Jerib Street.
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
Saeid Poursaadat
Position
Medical student / doctoral student dentistry
Other areas of specialty/work
Street address
School of dentistry, Isfahan University of Medical Sciences. Hezar Jerib Street.
City
Isfahan
Postal code
Phone
+98 31 1792 2870
Fax
+98 31 1792 2870
Email
Saeid_P22@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Doctor Ahmad Moghareh Abed
Position
Specialty in periodontics
Other areas of specialty/work
Street address
Department of periodontology, School of dentistry, Isfahan University of Medical Sciences.
City
Isfahan
Postal code
73461-81746
Phone
+98 31 1792 2870
Fax
+98 31 1792 2870
Email
Mogharehabed@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)