Objectives: The purpose of this study is to compare the clinical efficacy of manual Classic and manual Superbrush toothbrushes on plaque and bleeding indices.
Design: This clinical trial will be conducted on 30 volunteer dental students of dental school of Kerman medical university. After taking an informed consent, patients will be randomly divided into two groups with simple method: group A (Classic toothbrush; Soft, Tepe, sweden) and group B (Superbrush toothbrush; Soft, Dentaco AS, Haukeland, Norway).
Setting and conduct: A prophylaxis will be performed to achieve the plaque index of zero and then subjects are inhibited from doing any plaque control activity for 48 hours. Afterward the baseline plaque and bleeding point indices will be recorded and they will be given a common toothpaste (Crest). All participants will instruct to use both types of toothbrush for at least 3 minutes twice a day, using the Bass method without using dental floss. Each group will start the experiment with a different type of toothbrush for one week which will be followed by one week of washout. Then each group will switch to the next type of toothbrush for one week, and both plaque level and bleeding point indices will be recorded again with the same method, while the examiner is blind to trial type.
Participants including major eligibility criteria: They are systemically healthy and able to attend for the period of the trial, having at least 20 natural teeth and not having orthodontic appliances or implants.
Intervention: Using of the specified toothbrushes and not doing other oral hygiene procedures.
Main outcome: Removing the plaque from the teeth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051517619N3
Registration date:2015-06-27, 1394/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-27, 1394/04/06
Registrant information
Name
Fereshteh Moosaali
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 9023
Email address
moosaaly@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman university of medical sciences
Expected recruitment start date
2013-10-02, 1392/07/10
Expected recruitment end date
2013-11-05, 1392/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of clinical efficacy of manual Classic and manual Superbrush toothbrushes in plaque removing from the teeth surface of students
Public title
The efficacy of two manual toothbrushes on plaque and bleeding indices
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having at least 20 natural teeth. Exclusion criteria: Systemic disease that may effect the oral condition; caries; pregnancy; history of drug/alcohol abuse; smoking; presence of orthodontic appliances or implants; extensive restorations and periodontitis.
Age
From 19 years old to 30 years old
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman university of medical sciences
Street address
Kerman University of Medical Sciences, Shafa St.
City
Kerman
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
K/92/178
Health conditions studied
1
Description of health condition studied
Plaque and bleeding point indices
ICD-10 code
K05.6
ICD-10 code description
Periodontal disease, unspecified
Primary outcomes
1
Description
Plaque index
Timepoint
1st day, 7th day and two week after intervention
Method of measurement
O`Leary plaque index
2
Description
Bleeding point index
Timepoint
1st day, 7th day and two week after intervention
Method of measurement
Periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: brushing with classic toothbrush. The Classic toothbrush is a simple, straight-forward toothbrush. When used twice daily as part of an overall oral hygiene regimen that includes between-teeth cleaning, the Classic toothbrush will help to take good care of dental health.
Category
Prevention
2
Description
Intervention group 2: brushing with Superbrush toothbrush. Superbrush is a triple headed brush that cleans three surfaces of the teeth and gum margins simultaneously.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Vice Chancellor for Research, Kerman University of Medical Sciences, Kerman, Iran.
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Kerman University of Medical Sciences, Kerman, Iran.
City
Kerman
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, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Sasan Salahi
Position
Periodontist and member of dental school
Other areas of specialty/work
Street address
Periodontology department, Dental faculty, Kerman University of Medical Sciences, Shafa St., Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 3211 9023
Fax
Email
Sasan_salahi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Moosaali
Position
Periodontist and member of dental school
Other areas of specialty/work
Street address
Periodontology department, Dental faculty, Kerman University of Medical Sciences
City
Kerman
Postal code
Phone
+98 34 3211 9023
Fax
Email
moosaaly@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Moosaali
Position
Periodontist and member of dental school
Other areas of specialty/work
Street address
Periodontology department, Dental faculty, Kerman University of Medical Sciences
City
Kerman
Postal code
Phone
+98 34 3211 9023
Fax
Email
Moosaaly@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)