Comparison of effect of using dental floss before and after brushing on plaque index and gingival index of posterior teeth in dental students of Gorgan dental faculty
The main purpose of this study is to investigate the effect of flossing before and after brushing on plaque index and gingival index.
Design
The Crossover clinical trial study, Single randomized, Phase 3.
Settings and conduct
This study will be conducted in the Faculty of Dentistry, Golestan University of Medical Sciences.
Before starting the study, the plaque index( Silness & Loe)and the gingival index(Loe & Silness) will be measured. All people participating in the study will be given standard oral and dental hygiene training (Modified bass) including flossing by a periodontics.If the patients need scaling, it will be done. Measurements will be done at intervals of two weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Healthy physically and mentally
• Having all posterior permanent teeth except wisdom teeth
• Age between 20 and 40 years
• No active caries or extensive restorations or veneers on the posterior teeth
Exclusion criteria
• People with orthodontic braces
• People without interdental contact
• Severe dental irregularity
• Periodontal problems
• Having a systemic disease affecting the periodontium tissue
• Use of systemic drugs affecting periodontal tissue
• Alcohol and smoking
• Pregnancy and breastfeeding
• Taking antibiotics for one week in the last three months
Intervention groups
This study is Cross-over
Use dental floss before brushing
Use dental floss after brushing
Main outcome variables
Plaque Index ، Gingival Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231123060153N2
Registration date:2024-07-21, 1403/04/31
Registration timing:retrospective
Last update:2024-07-21, 1403/04/31
Update count:0
Registration date
2024-07-21, 1403/04/31
Registrant information
Name
Amir reza Ahmadinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3253 6270
Email address
ar.ahmadinia@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-04-03, 1403/01/15
Actual recruitment start date
2023-04-05, 1402/01/16
Actual recruitment end date
2024-04-06, 1403/01/18
Trial completion date
2024-05-18, 1403/02/29
Scientific title
Comparison of effect of using dental floss before and after brushing on plaque index and gingival index of posterior teeth in dental students of Gorgan dental faculty
Public title
The effect of flossing and brushing on plaque and gingival index
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Physically and mentally healthy people
Having all posterior permanent teeth except wisdom teeth
People aged between 20 and 40 years
Exclusion criteria:
People with orthodontic appliances
People without interdental contact
Crowding and malposition of posterior teeth
People with periodontal disease
Active caries or extensive restorations or crown of posterior teeth
Having a systemic disease affecting the periodontal tissue
Taking medications that affect periodontal tissue
Consumption of alcohol and cigarettes
Pregnancy and lactating
Taking antibiotics in the last three months for one week.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization of study groups:
In the first stage, people are randomly divided into toothbrush-dental floss (A) and dental floss-toothbrush (B) groups. Random block method will be used to assign people to groups. For this purpose, all six positions of letters A and B are considered in blocks of four.
Table 1: Table 1: Generated random block
(1) AABB
(2)BBAA
(3)ABAB
(4)BABA
(5)ABBA
(6)BAAB
To allocate 16 students in each group (32 people in total), 8 blocks of 4 are needed. To select 8 blocks first, 8 random numbers between 1 and 6 will be generated by repetition (with placement). Thus, a sequence of letters A and B will be created containing 32 letters (16 letters A and 16 letters B).
The random numbers generated in the R software and the random block attributed to the numbers generated using the above table are as follows
Block number Randomly generated number Attributed block
1 4 BABA
2 5 ABBA
3 6 BAAB
4 6 BAAB
5 1 AABB
6 2 BBAA
7 4 BABA
8 3 ABAB
For example, the first person who meets the study entry criteria is in group B, the second person is in group A, the third person is in group B, and the fourth person is in group A. And it continues until 32 people respectively. People are matched in terms of age and sex.
Blinding (investigator's opinion)
Single blinded
Blinding description
The examiners are not aware of the type of intervention (single blind).
Placebo
Not used
Assignment
Crossover
Other design features
In this study, referring to Turkezban et al.'s study (11) with a confidence level of 0.95 and a test power of 0.80, and taking into account the purpose of comparing the average plaque index before and after using the following formula, a total of 32 people were randomly sampled. students will be selected from the community under study. The students will be assigned to two groups by block allocation, the first group will use toothbrush-dental floss for two weeks and the second group will use dental floss-brush and after two weeks, its plaque index and gingival index will be measured. and two weeks of wash out will be taken into account and after that their plaque index and gingival index will be measured and again the students of the first group will first use dental floss-brush and the second group will use toothbrush-floss and after two weeks the plaque index And the gingival index will be measured.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Gorgan, Shahrek Shahryar, Shahryar 5, Gorgan Faculty of Dentistry
City
Gorgan
Province
Golestan
Postal code
4916648679
Approval date
2022-07-03, 1401/04/12
Ethics committee reference number
IR.GOUMS.REC.1401.129
Health conditions studied
1
Description of health condition studied
Gingival Index, Plaque Index
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Gingival Index، Plaqe Index
Timepoint
Before starting the intervention in both groups، Two weeks after intervention in each group, two weeks after cleansing, two weeks after intervention
Method of measurement
For the gingival index variable, we first measured the four surfaces of the teeth with the help of a probe and if 0: normal gums, 1: mild inflammation, slight color change, no swelling, no BOP2: moderate inflammation, redness, swelling and glossiness of the gums with BOP3: severe inflammation with Redness and swelling, wounds and continuous bleeding, and for the index plaque variable from Fuchsin tablets, which is based on the amount of tooth surface color using the following formula (number of teeth)/(teeth 100 (percentage) x 4)
Secondary outcomes
1
Description
Gingival Index ، Plaqe Index
Timepoint
Before starting the intervention in both groups، Two weeks after intervention in each group, two weeks after cleansing, two weeks after intervention
Method of measurement
For the gingival index variable, we first measured the four surfaces of the teeth with the help of a probe and if 0: normal gums, 1: mild inflammation, slight color change, no swelling, no BOP2: moderate inflammation, redness, swelling and glossiness of the gums with BOP3: severe inflammation with Redness and swelling, wounds and continuous bleeding, and for the index plaque variable from Fuchsin tablets, which is based on the amount of tooth surface color using the following formula (number of teeth) devided (teeth 100 (percentage) x 4)
Intervention groups
1
Description
Intervention group: using a toothbrush after using dental floss
Category
Behavior
2
Description
Control group: using dental floss after using a toothbrush
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan dental faculty
Full name of responsible person
Amirreza Ahmadinia
Street address
2nd Floor, Research and Technology Vice-Chancellor، Golestan University of Medical Sciences Higher Education Complex، 1st Shasat Kolah Road
City
Gorgan
Province
Golestan
Postal code
4916648679
Phone
+98 17 3234 4830
Email
ar.ahmadinia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Amirreza Ahmadinia
Street address
Golestan university of medical sciences
City
gorgan
Province
Golestan
Postal code
4916648679
Phone
+98 17 3234 4830
Email
ar.ahmadinia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Amir reza Ahmadinia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Valiasar street
City
Gorgan
Province
Golestan
Postal code
4916648679
Phone
+98 17 3253 6270
Fax
Email
ar.ahmadinia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Amir reza Ahmadinia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Valiasar street
City
Gorgan
Province
Golestan
Postal code
4916648679
Phone
+98 17 3253 6270
Fax
Email
ar.ahmadinia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Amir reza Ahmadinia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Valiasar street
City
Gorgan
Province
Golestan
Postal code
4916648679
Phone
+98 17 3253 6270
Fax
Email
ar.ahmadinia@gmail.com
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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The documents will be attached to the file.
When the data will become available and for how long
The access period starts from 1402
To whom data/document is available
Everyone can access the documents.
Under which criteria data/document could be used
If the requesters need, the data will be sent to them.
From where data/document is obtainable
By sending an email to the responsible author, the data will be sent to the requester.
What processes are involved for a request to access data/document
By sending an email to the responsible author, the data will be sent to the requester.