determining the effect of chewing Eucalyptus gum on accumulation of microbial plaque on different surfaces of tooth.
Design
Study is a crossover randomized clinical trial with control group, Not Randomized, Not blinded
Settings and conduct
study is conducted over two 3-day period with a 4-day break between them in dental clinic of Hormozgan university of medical science. At the beginning of each period individuals' Plaque index is measured and then according to the protocol they are given gum; after the end of each period, individuals' plaque index will be measured again.
Participants/Inclusion and exclusion criteria
participants should have full oral and dental health(without rampand caries and bleeding on probing) and without underlying disease,without orthodontic brackets and without severe dental crowding
Intervention groups
Intervention group1: They chew 4 pieces of gums contain Eucalyptus extract(Orbit ,Wrigley company) for 20 minutes after main meals and 1 piece after afternoon snack daily(for 3 days)
Intervention group2: They chew 4 pieces of plain gums from same company for 20 minutes after main meals and 1 piece after afternoon snack daily(for 3 days)
Because the study is crossover design so each intervention group is its control too so in the second period which is 4 days after first period , intervention and control group will switch and the process will repeat.
Main outcome variables
Accumulated dental plaque on different dental surfaces
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190715044223N1
Registration date:2020-04-09, 1399/01/21
Registration timing:retrospective
Last update:2020-04-09, 1399/01/21
Update count:0
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
Sara Achangan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3223 4030
Email address
sara.achangan@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-01, 1398/08/10
Expected recruitment end date
2020-01-30, 1398/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the Effect of eucalyptus chewing gum on reduction of microbial plaque of dental students
Public title
The effect of Eucalyptus chewing gum on microbial plaque
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Participants should have full oral and dental health ( without rampant caries and bleeding on probing)
Individuals without underlying disease
Individuals without orthodontic brackets
Individuals without severe dental crowding
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization method. We use a block size of 4 to do this and we assume that we have gum A and gum B ;There are 6 possible arrangement for blocks : AABB - ABAB - BAAB - BABA - BBAA - ABBA .We randomly choose one block for example ABAB , Then we enroll 30 participants and number them from 1 to 30 ;Then for the first four participants we choose this permuted block randomization scheme:
ABAB : gumA=participant1 /gumB=participant2 / gumA=participant3 / gumB=participant4
Then we randomly choose another block for the participants number 5 to 8 ; Then this trend will be repeated.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Hormozgan University of Medical Sciences
Street address
19th Rahil alley , Shahid kazerouni street
City
Bandarabbas
Province
Hormozgan
Postal code
7914857179
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.HUMS.REC.1397.325
Health conditions studied
1
Description of health condition studied
Accumulation of microbial plaque
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Accumulated dental plaque on different dental surfaces
Timepoint
Before the beginning of the intervention and after the third day of each period
Method of measurement
Dental plaque measurement using Detector tablets on smooth surfaces using Oleary index and M.Addy in occlusal surface
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: half of the participants during a 3-day period use 4 pieces of Eucalyptus gum daily (Orbit Wrigley company) for 20 minutes after meals and 1piece after afternoon snack , after 4 days of wash out period ,participants during a 3-day period use 4 pieces of plain gum as placebo (Orbit Wrigley company) daily for 20 minutes after main meals and 1piece after afternoon snack.
Category
Diagnosis
2
Description
Intervention group2: half of the participant during a 3-day period use 4 pieces of plain gum as placebo (Orbit Wrigley company) daily for 20 minutes after main meals and 1piece after afternoon snack. after 4 days of wash out period , participants during a 3-day period use 4 pieces of Eucalyptus gum daily (Orbit Wrigley company) for 20 minutes after meals and 1piece after afternoon snack
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental clinic of Hormozgan Univrsity of medical science
Full name of responsible person
Sara Achangan
Street address
19th Rahil Alley , Shahid Kazerouni Street
City
Bandarabbas
Province
Hormozgan
Postal code
7914857179
Phone
+98 76 3223 4030
Email
sara.achangan@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Teymour Aghamollaee
Street address
Research and Technology Dept., East Side of Shahid Mohammadi Hospital, Islamic Republic of Iran Blvd., Bandar Abbas
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 7192
Email
taghamolaei@hums.ac.ir
Web page address
https://resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sara Achangan
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
19th Rahil alley, Shahid Kazerouni street
City
Bandarabbas
Province
Hormozgan
Postal code
7914857179
Phone
+98 76 3223 4030
Fax
Email
sara.achangan@hums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Arezou Rayani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
19th Rahil alley,Shahid Kazerouni street
City
Bandarabbas
Province
Hormozgan
Postal code
7914857179
Phone
+98 76 3223 4030
Email
Arezoo.rayyani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sara Achangan
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
19th Rahil alley, Shahid Kazerouni street
City
Bandarabbas
Province
Hormozgan
Postal code
7914857179
Phone
+98 76 3223 4030
Fax
Email
sara.achangan@hums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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