Determining the effect of brushing and flossing sequence on the reduction of interdental plaque in young subjects with intact papilla
Design
The sampling method is available from dental students of Qazvin Dental School. This study will have two phases. There will be a two-week interval between the two phases to eliminate the effect of the first phase of the study. The sample size was estimated at 37 people.
Settings and conduct
Participants will be given a soft toothbrush, toothpaste and floss. This study will be done in two phases and each phase will last 48 hours. There will be a two-week interval between the two phases. Before the start of each phase for individuals Professional prophylaxis will be performed with rubber cup and prophylaxis paste. They will then be asked to refrain from any activity for 48 hours to control plaque and maintain oral hygiene. After 48 hours, participants will randomly enter the first group (brush). -floss) or the second group (floss-brush).
Group 1 (brush-floss): First, participants will be given a disclosing detector tablet. Then the index plate will be taken by Rustogi Modified navy plaque index method. Then the toothbrush with modified bass method for 2 minutes and then floss for 2 minutes will be used. Then the index plate will be registered again.
The second group (Floss-brush): All the steps are similar to the first group, except that first floss and then toothbrush will be used.
Participants/Inclusion and exclusion criteria
Participants will be dental students of Qazvin Dental School, whose average age is 20 to 25 years. Individuals must meet the inclusion criteria
Intervention groups
Before each study phase, prophylaxis will be performed for participants with a brush and prophylaxis paste.
Main outcome variables
Reduction of interdental plaque
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210803052063N1
Registration date:2021-11-06, 1400/08/15
Registration timing:prospective
Last update:2021-11-06, 1400/08/15
Update count:0
Registration date
2021-11-06, 1400/08/15
Registrant information
Name
Fahimeh AliAkbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3355 5625
Email address
aliakbaryfahimeh977@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-05, 1400/09/14
Expected recruitment end date
2022-01-04, 1400/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of brushing and flossing sequence on interdental plaque reduction in young subjects with intact papilla; cross over clinical trial
Public title
The efficacy of brushing and flossing sequence on plaque
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Does not exist crown on teeth
Having all their permanent teeth(except third molars)
Individuals with a normal unstimulated salivary flow rate
Individuals free from cavitated carious lesions
Intact papilla at interdental area
Exclusion criteria:
Systemic illness or periodontitis
Severe crowding
Gingival recession
Diastema
Age
From 20 years old to 25 years old
Gender
Both
Phase
2
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. The method of randomization is that a person other than the facilitator of the envelope will give statistics to the participants according to the list of consultants and they will be asked to implement the envelope about the content of the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the performer and statistical analyzer will be blind until after data analysis. First, the list is prepared by a statistical consultant, in which sequence do the numbers 1 to 37 enter first, and in each phase, first brush or floss? Then, a person other than the presenter randomly selects a number from 1 to 37 for each person and categorizes the statistics of the people according to the list. The paper is given to the participants for each person who enters the sequence first. While studying, brushing and flossing leaves the presenter alone to be completely blind
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Bahonar blvd. Qazvin university of medical science
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Approval date
2021-06-07, 1400/03/17
Ethics committee reference number
IR.QUMS.REC.1400.106
Health conditions studied
1
Description of health condition studied
Dental plaque
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Calculation of dental plaque using modified navy plaque index
Timepoint
The study will be conducted in two phases. On the first day of the first phase of prophylaxis and on the third day of the first phase, the index plate will be recorded. After two weeks, on the first day of the second phase of prophylaxis and on the third day of the second phase, the index plate will be registered.
Method of measurement
Modified navy plaque index
Secondary outcomes
empty
Intervention groups
1
Description
This is a crossover study that will performed in two phases. At the beginning of each phase, prophylaxis will be performed for the participants for all dental surfaces using golchadent prophylaxis Paste, Golchai co, Alborz, Iran prophylaxis brush and prophylaxis paste. they will asked to discontinue all forms of oral hygiene for 48 hours.In one phase, they will first brush, then floss. In the other phase they initially will use dental floss then brush.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Fahimeh Ali Akbari
Street address
Qazvin University of Medical Sciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Mahdi Mirhashemi
Street address
Qazvin Univrsity of Medical Sciences, Bahonar blvd.
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3335 3061
Email
sm.mirhashemi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fahimeh Ali Akbari
Position
dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Qazvin University of Medical Ssciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
15315_34199
Phone
+98 28 3333 6001
Email
aliakbaryfahimeh977@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fahimeh Ali Akbari
Position
dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Qazvin University of Medical Ssciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
15315_34199
Phone
+98 28 3333 6001
Email
aliakbaryfahimeh977@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fahimeh Ali Akbari
Position
dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Qazvin University of Medical Ssciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3333 6001
Email
aliakbaryfahimeh977@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All shareable information except people's names
When the data will become available and for how long
Access starts 3 months after the results are published
To whom data/document is available
The fable community is accessible to everyone
Under which criteria data/document could be used
The use of data is free to the public
From where data/document is obtainable
Qazvin Dental School Library
What processes are involved for a request to access data/document