Determining the effect of commercial charcoal floss and ordinary floss on periodontal indices
Design
This study will be performed in the center of the Faculty of Dentistry of Ardabil University of Medical Sciences, as a double -blind (researcher and study analyst) and as a randomized clinical trial.
Settings and conduct
Among students studying at dental school, 50 people who meet the criteria will participate in the study after receiving written consent. Each person will be given the necessary training and they will be asked to use the given tooth floss as a split-mouth. After a period of time, the studied indicators will be evaluated. Finally, the effect of commercial charcoal floss and conventional floss in reducing gingivitis will be investigated.
Participants/Inclusion and exclusion criteria
Exclusion criteria: systemic diseases that cause changes in periodontal health such as diabetes, hormonal problems, patients at risk for endocarditis, pregnant and lactating women; visual diagnosis of any malocclusion such as crowding, cross-bite, open bite, etc; history of chronic use of any antibiotics or drugs that affect the condition of the periodontium such as phenytoin or cyclosporine at least the last 3 months; chronic use of NSAIDs; history of any harmful oral habits such as bruxism, clenching; chewing with theone side mouth.
Inclusion criteria: at least 5 teeth in each quadrant; at least one dental space in each quadrant of bleeding during the probe (BOP); maximum depth of the envelope is 2 mm and there is no gingival resorption; maximum space between the teeth should be 1 mm.
Intervention groups
Intervention group: Charcoal dental floss
Control group: normal dental floss
Main outcome variables
plaque index; gingival index; bleeding on probing index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210305050584N2
Registration date:2021-12-04, 1400/09/13
Registration timing:registered_while_recruiting
Last update:2021-12-04, 1400/09/13
Update count:0
Registration date
2021-12-04, 1400/09/13
Registrant information
Name
Sheida Fazlalizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3324 9753
Email address
sh.fazlalizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-10, 1400/08/19
Expected recruitment end date
2022-03-17, 1400/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of the efficacy of commercial charcoal tooth floss and conventional tooth floss in Periodontal indices:randomized clinical trial
Public title
The assessment of the efficacy of commercial charcoal tooth floss and conventional tooth floss in Periodontal indices
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
At least 5 teeth in each quadrant.
At least one dental space in each quadrant of bleeding during the probe (BOP).
The maximum depth of the pocket equal to 2 mm and no gingival resorption.
A maximum interdental space of 1 mm.
Exclusion criteria:
Systemic diseases that cause changes in periodontal health,such as diabetes,hormonal problems,patients at risk for endocarditis,pregnant women and nursing mothers.
Malocclusion.
Use of systemic antibiotics in the last 3 months before the start of the study.
History of any harmful oral habits such as bruxism, clenching.
Chewing with the one side of mouth.
Consumption of mouthwash in the last 6 months.
Smoking.
Pregnancy.
Periodontal surgery: In case of periodontal surgery within 6 months before the study in the study area.
Oral mucosal diseases (such as vesiculosis-bullous diseases).
Periodontal disease: If attachment loss more than 2 mm.
Any type of dental prosthesis appliances, orthodontics, cavities or any plaque blocking agent other than calculus.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of samples will be done by lottery method. Inside the sealed envelopes, half of the samples will contain an A card and half of the samples will contain a B card, and the samples will randomly pick up a card from the envelope. Each specimen that removes card A will floss its right quadrant (quadrant) with charcoal floss and its two left quadrants with conventional floss, and each specimen that removes card B will floss its two right quadrants with conventional floss and two left quadrants will floss with charcoal floss
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the distinction between charcoal and normal floss, there is no ability to blind the participant.The analyst of the study data and the person measuring the indexes (researcher) do not know in which group the samples are.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical science-Dentistry Faculty
Street address
Daneshgah alley, Ardebil University of Medical since
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.ARUMS.REC.1400.221
Health conditions studied
1
Description of health condition studied
gingivitis
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
plaque index
Timepoint
Start of study and the second, fourth and eighth week after the intervention
Method of measurement
Turesky modified Quigley-hein index
2
Description
Bleeding on probing index
Timepoint
Start of study and the second, fourth and eighth week after the intervention
Method of measurement
Ainamo &Bay bleeding on probing index
3
Description
gingival index
Timepoint
Start of study and the second, fourth and eighth week after the intervention
Method of measurement
Loe Silness index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use charcoal floss once a day before bed for 2 months.
Category
Prevention
2
Description
Control group: Use conventional toothfloss once a day before bed for 2 months.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil University of Medical science-Dentistry Faculty
Full name of responsible person
Dr.Sheida Fazlalizadeh
Street address
Daneshgah alley, Ardebil University of Medical since
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Email
sh.fazlalizadeh@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr.Sheida Fazlalizadeh
Street address
Daneshgah alley, Ardebil University of Medical since
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Email
sh.fazlalizadeh@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr.Sheida Fazlalizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah alley, Ardebil University of Medical since
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Email
sh.fazlalizadeh@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr.Sheida Fazlalizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah alley, Ardebil University of Medical since
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Email
sh.fazlalizadeh@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Amirreza Rakhshanpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Daneshgah alley, Ardebil University of Medical since
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Email
amir_rakhsh@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
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
part of datas
When the data will become available and for how long
access period starts 6 months after the results are published
To whom data/document is available
researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutes can request access to data and documents only for the purpose of scientific and research work and in order to improve scientific resources.
From where data/document is obtainable
Dr. Sheida Fazlalizadeh : sh.fazlalizade@gmail.com
Amirreza Rakhshanpour :amir_rakhsh@yahoo.com
What processes are involved for a request to access data/document
Dr. Sheida Fazlalizadeh : sh.fazlalizade@gmail.com
Amirreza Rakhshanpour :amir_rakhsh@yahoo.com
Comments
Requests will be answered via email as soon as possible.