Protocol summary

Study aim
Clinical comparison of two types of dental floss on interdental plaque removal and gingival health
Design
double_blind clinical trial , with parallel groups , randomized , phase 3 on 50 people
Settings and conduct
this study is a randomized clinical trial on 50 dental students of Kurdistan University of Medical Sciences.The patients are selected according to the entry and exit criteria. The patients are divided into two groups of 25. The first group was given expanding dental floss and the second group was given simple waxed dental floss, and the patients asked to use it twice a day, morning and night, for 6 weeks. Then, four scales are used to measure the amount of dental plaque, gingivitis and bleeding on probe.
Participants/Inclusion and exclusion criteria
Entry conditions: patients with generalized gingivitis and plaque index below 2 Conditions of non-entry: use of drugs affecting periodontium, pregnancy, use or history of smoking, malocclusion, history of orthodontic treatment, oral mucosa disease, people with chronic systemic diseases (copulative diseases, kidney diseases, diabetes and any other diseases) which affects the periodontal condition of the person), depth of pocket more than 3 mm, use of antibiotics, use of mouthwash, periodontal surgery in the last 6 months, the presence of calculus below and above the gums
Intervention groups
patients are randomly divided in two groups.(A expanding floss and B simple waxed floss)
Main outcome variables
interdental plaque , gingival health

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220726055559N3
Registration date: 2023-11-09, 1402/08/18
Registration timing: registered_while_recruiting

Last update: 2023-11-09, 1402/08/18
Update count: 0
Registration date
2023-11-09, 1402/08/18
Registrant information
Name
Shabnam Khalifehzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 2260
Email address
shabnam.kh63ii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-08, 1402/08/17
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical comparison of two types of dental floss on interdental plaque removal and gingival health
Public title
comprasion the effect of two types of dental floss on interdental plaque
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with generalized gingivitis Plaque index< 2
Exclusion criteria:
History of orthodontic treatment patients with systemic chronic diseases patients with oral mucosal diseases periodontal surgery in last 6 months
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The purpose of block randomization is that equal number of participants enter the intervention and control groups. The size of each block is 25 people. In this way, expanding floss is assigned to the first block and simple waxed floss to the second block to be.
Blinding (investigator's opinion)
Double blinded
Blinding description
expanding floss and simple waxed floss are named with two letters B&A and will be given to two equal groups of patients. The patients are selected with the minimum entry criteria. There are 25 patients in each group. It will be fully explained to the patients. Written informed consent will be obtained from the patients. The patients will be selected by sampling based on the entry criteria and will be randomly divided into two equal groups. Group A is expanding floss and the group B will use simple waxed floss. Participants and health personnel will not know the type of toothpaste.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Science
Street address
Kurdistan University of Medical Science, Pasdaran Ave
City
sanandaj
Province
Kurdistan
Postal code
661713446
Approval date
2023-08-28, 1402/06/06
Ethics committee reference number
IR.MUK.REC.1402.133

Health conditions studied

1

Description of health condition studied
interdental plaque
ICD-10 code
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced

Primary outcomes

1

Description
interdental plaque and gingival health
Timepoint
Measure the indexes at the beginning of the study, 21 and 42 days later
Method of measurement
PI (Silness_Loe plaque index) with 0-3 score . IPI (interdental pressure index) with posetive and negetive . GI(Silness_loe gingival index) with 0-4 score . PBI (papillary bleeding index) with 0-4 score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: AThey receive expanding floss.They use floss twice a day for 42 days .
Category
Treatment - Drugs

2

Description
Intervention group: B AThey receive simple waxed floss.They use floss twice a day for 42 days .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kurdistan University of Medical Sciences
Full name of responsible person
zahra zabihi rizi
Street address
Kurdistan University of Medical Sciences,Pasdaran Ave
City
sanandaj
Province
Kurdistan
Postal code
661713446
Phone
+98 87 3366 4643
Email
za.mahra.1921@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
afshin maleki
Street address
Pasdaran Ave
City
sanandaj
Province
Kurdistan
Postal code
661713446
Phone
+98 87 3366 4645
Email
Maleki@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
zahra zabihi rizi
Position
dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
kooshk building , nooh Alley , shalman st.
City
sanandaj
Province
Kurdistan
Postal code
6617974688
Phone
+98 87 3377 1661
Email
za.mahra.1921@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
shabnam khalifehzade
Position
Associate Profesosr
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 5,Shaghayegh Alley,Lotfi Ave,Shalman Blvs,Sanandaj City
City
sanandaj
Province
Kurdistan
Postal code
6617975413
Phone
+98 87 3362 2260
Email
Shabnam.kh63ii@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
zahra zabihi rizi
Position
dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
kooshk building , Nooh Alley , Shalman st.
City
sanandaj
Province
Kurdistan
Postal code
6617974688
Phone
+98 87 3377 1661
Email
za.mahra.1921@gmail.com

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
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