Evaluation of the effect of chewing apple and toothbrushing on dental plaque removal in dental students
Design
48 dental students (24 females and 24 males) of Hamadan dental school whose ages were between 20 to 25 years with good oral hygiene are randomly selected after obtaining informed consent.
Students are given a complete description of the study process such as performing the Bass Technique and the duration of each phase.
There is a 2 week interval after each group completed their first phase.
Settings and conduct
The students are divided into two groups randomly without using any other complementary plaque control techniques for 24 hours.
The plaque index was determined at 3 points:
1. At baseline (after prophylaxis and sample matching)
2. Immediately after performing the plaque removal technique.
3. 24 hours after completing the removal technique
For 24 hours after completing the removal technique, participants do not perform their routine oral hygiene techniques, drink alcohol or consume food that could promote mechanical plaque removal, although they maintain their usual dietary habits.
The O'Leary index is used to record dental plaque and the plaque index is recorded in the dental chart by using disclosing tablets in the morning (between 9 o'clock to 12). Patients are asked to hold TEPe plaqsearch tablets in their mouths for 30 seconds to mix with their saliva and subsequently spread them to all tooth surfaces with their tongues.
Participants/Inclusion and exclusion criteria
1. Good oral hygiene ( plaque index must be below 20%)
2. 24 examinable teeth (excluding third molars and teeth with crown, active caries and cavitated teeth and orthodontic appliances)
Comparison between the effects of chewing apple and tooth brushing on dental plaque in dental students of Hamadan in 1399 : A clinical trial
Public title
Comparison of the effect of chewing apple and tooth brushing on dental plaque
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Good oral hygien (plaque index below 20%)
24 examinable teeth (excluding third molar and teeth with prosthetic treatment, active caries and cavity and orthodontic appliance)
Exclusion criteria:
Smoking
Fixed or removable prosthesis
History of antibiotic and antiseptic mouthwash consumption for the past 3 months
Systemic problem or consumption of saliva-decreasing medications
Age
From 20 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave. Hamadan, Islamic Republic of Iran.
City
Hamadan
Province
Hamadan
Postal code
65417838741
Approval date
2019-12-23, 1398/10/02
Ethics committee reference number
IR.UMSHA.REC.1398.772
Health conditions studied
1
Description of health condition studied
Dental plaque
ICD-10 code
K03.6
ICD-10 code description
بیماریهای بافتهای سخت دندانها
Primary outcomes
1
Description
Decrease in dental plaque
Timepoint
1. Baseline, before scaling and matching samples immediately after tooth brushing/ chewing apple 3. 24 hours after tooth brushing/ chewing apple
Method of measurement
Plaque index (O'Leary index) and disclosing tablet
Secondary outcomes
empty
Intervention groups
1
Description
chewing apple: Apples must be consumed along with their peel and the apples used are golden, with a mean weight of 160 grams. Mastication was performed with both sides of the mouth with no time limit. Consumption of apples in 24 hours is intervention number 1.
Category
Prevention
2
Description
tooth brushing: medium toothbrush (Oral-B 123 classic care medium)and sterile water (10 mL), with no toothpaste. The Bass tooth brushing technique is implied for a total of two minutes (30 seconds per quadrant of the oral cavity). There is a one time frequency for brushing in 24 hours.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatric Dentistry, Hamadan University of Medical Sciences
Full name of responsible person
Niloofar Entezari
Street address
Pediatric Dentistry Department, Hamadan University of Medical Sciences, Shahid Fahmideh Ave. Hamadan, Islamic Republic of Iran.
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Email
niloufal2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Deputy of research and technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave. Hamadan, Islamic Republic of Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Niloofar Entezari
Position
Resident of pediatric dentistry.
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Pediatric Dentistry Department, Hamadan University of Medical Sciences, Shahid Fahmideh Ave. Hamadan, Islamic Republic of Iran.
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Email
niloufal2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Niloofar Entezari
Position
Resident of pediatric dentistry.
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Pediatric Dentistry Department, Hamadan University of Medical Sciences, Shahid Fahmideh Ave. Hamadan, Islamic Republic of Iran.
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Email
niloufal2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Niloofar Entezari
Position
Resident of pediatric dentistry.
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Pediatric Dentistry Department, Hamadan University of Medical Sciences, Shahid Fahmideh Ave. Hamadan, Islamic Republic of Iran.
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Email
niloufal2@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The study data file will be used only in the present study.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The published article of the study is accessible under the relevant rules by citation.
When the data will become available and for how long
From the time the results were published until Hamadan University of Medical Sciences granted access to the data.
To whom data/document is available
Hamadan University of Medical Sciences users
Under which criteria data/document could be used
In order to be used in research similar to the citation requirement in the references.
From where data/document is obtainable
To the website of Hamadan University of Medical Sciences or responsible author.
What processes are involved for a request to access data/document