Determine the effect of chewing gum on the formation of plaque in smooth surfaces
Design
In this study, 18 people with complete oral and dental health who are eligible for entering the study are chosen among people who refer to the dental school. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
This study is performed on a randomized clinical trial in the dental school. This study is done in a one-way blind fashion, so that someone who measures the indexes is not aware that which group have used gum and which group is without chewing gum.
Participants/Inclusion and exclusion criteria
The participants are from the dental faculty
Entry requirements: Full health of the mouth and teeth
Conditions of non-entry: People with underlying disease and rapidly progressive caries and orthodontic bracket and severe dental arrhythmias
Intervention groups
Case group: A group giving them chewing gum.
Control group: A group that does not have chewing gum.
Main outcome variables
O'Leary index: Measuring dental plaque on smooth surfaces
Bleeding index: Assessment of bleeding gums around each tooth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171015036782N4
Registration date:2018-04-28, 1397/02/08
Registration timing:retrospective
Last update:2018-04-28, 1397/02/08
Update count:0
Registration date
2018-04-28, 1397/02/08
Registrant information
Name
farzane vaziri
Name of organization / entity
Shahid sadoughi dental university
Country
Iran (Islamic Republic of)
Phone
+98 35 3620 4764
Email address
f.vaziri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences Yazd
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of chewing gum on the formation of plaque on the smooth surface theeth
Public title
The effects of chewing gum on the formation of plaque on the smooth surface theeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Full health of the mouth and teeth
Exclusion criteria:
Underlying disease and rapidly progressive caries with orthodontic bracket and severe dental irregularities
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random allocation software, so 18 eligible patients randomly divide into two groups of 9 patients with making special codes.
Blinding (investigator's opinion)
Not blinded
Blinding description
The outcome evaluator
The person who measures the indexes does not know which group is chewing gum and which group is not chewing gum.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
yazd.Bahonar Square
City
yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
ir.ssu.rec.1396.69
Health conditions studied
1
Description of health condition studied
gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
bleeding index
Timepoint
Once at the end of the period
Method of measurement
Evaluation of the bleeding gingiva around each tooth as percentage
2
Description
o,leary index
Timepoint
Once at the end of the period
Method of measurement
Measuring dental plaque on flat surfaces as percentages
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, for the two days of intervention, they receive four BIODENT chewing gum made in Iran, which can be used for 20 minutes after three meals and one after evening snack.
Category
Prevention
2
Description
The control group does not receive any intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental college
Full name of responsible person
Farzaneh al-Sadat Vaziri
Street address
End of Imam Street, Imam Reza Square, Imam Reza Blvd.
City
yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 0344
Email
F.VAZIRI@SSU.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Amir Houshang Mehrparvar
Street address
Yazd Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Farzaneh al-Sadat Vaziri
Position
Periodontology specialist / assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Street address
End of Imam Street, Imam Reza Square, Imam Reza Blvd.
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 0344
Fax
Email
www.f.vaziri@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Farzaneh al-Sadat Vaziri
Position
Periodontology specialist / assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Yazd Green Space Faculty of Dentistry
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Fax
Email
www.f.vaziri@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Farzaneh al-Sadat Vaziri
Position
Periodontology specialist / assistant professor
Latest degree
Specialist
Other areas of specialty/work
Street address
End of Imam Street, Imam Reza Square, Imam Reza Blvd.
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Fax
Email
www.f.vaziri@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The whole data is shared
When the data will become available and for how long
5 months after the publication of the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Email, phone call
From where data/document is obtainable
Maryam al-Sadat Kamal al-Dini 09131584672
kamaladdini1373@gmail.com
What processes are involved for a request to access data/document
After sending the data, the data will be transmitted