Study and comparison between effect of oral irrigator and dental floss as supplement of toothbrush on periodontal index at patients with gingivitis.
Design
Clinical trial with control group and parallel groups, single blind, randomized, phase 2 and 3 groups on 40 patients. A randomized table of numbers was used for randomization.
Settings and conduct
The study is located in periodontology department of Mashhad Dental School. In the intervention group, each participant will be given an oral irrigator(waterjet) and a toothbrush to compare the effect of waterjet on reducing gingival index, plaque index and bleeding on probe after 14 and 28 days. In the control group, each participant will be given toothbrushes and floss and after 14 and 28 days, we will measure the mentioned indicators. In this study, blinding was performed by using closed envelopes. The outcome stabilizer is not aware of the intervention method in the groups.
Participants/Inclusion and exclusion criteria
1.Generalized gingivitis.
2.Gingival index( Loe and Sillness Gingival Index ) 1 or more.
3.Bleeding on probing at more than 10 percent of teeth.
4.Participant not affected by systemic diseases associated with periodontal conditions.
5.Not pregnancy.
6.The patients without periodontal treatments within 1 month ago.
Intervention groups
In the intervention group, each participant will be given an oral irrigator(waterjet) and a toothbrush to compare the effect of waterjet on reducing gingival index, plaque index and bleeding on probing after 14 and 28 days. In the control group, each participant will be given toothbrushes and floss and after 14 and 28 days, we will measure the mentioned indicators.
Main outcome variables
Gingivitis; Plaque index; Oral health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211221053478N1
Registration date:2022-07-27, 1401/05/05
Registration timing:prospective
Last update:2022-07-27, 1401/05/05
Update count:0
Registration date
2022-07-27, 1401/05/05
Registrant information
Name
Sajjad Niroumand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3880 0944
Email address
niroumands951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-12, 1401/05/21
Expected recruitment end date
2022-09-12, 1401/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral irrigator on periodontal indices in patients with generalized gingivitis
Public title
The effect of oral irrigator on patients with gingival inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Generalized gingivitis
Gingival index( Loe and Sillness Gingival Index ) 1 or more
Bleeding on probing at more than 10 percent of teeth
Exclusion criteria:
Pregnancy
The patients under periodontal treatments within 1 month ago
Systemic diseases associated with periodontal conditions
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly assigned to the intervention and control groups by block randomization using a table of random numbers. Sealed envelop were used for allocation of random numbers to the patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients could not be blinded to the allocated procedure. However, the examiner who examine the plaque index, gingival index and bleeding on probing after the intervention was blinded to the group allocation of patients. Thus, the study had a single-blinded design. The statistician who analyzed the data was also blinded to the group allocation of patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Beginning of Vakilabad Ave., In front of Mellat Park ., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1400.118
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced
Primary outcomes
1
Description
Percentage of people with gingival index 1 or higher
Timepoint
Measurement of gingival index at the beginning of the study and 14 and 28 days after starting using dental floss and waterjet.
Method of measurement
Clinical examination and direct observation of gingival changes.
Secondary outcomes
1
Description
Bleeding on probing in more than 10 percent of teeth
Timepoint
Measurement of Bleeding on probing at the beginning of the study and 14 and 28 days after starting using dental floss and waterjet.
Method of measurement
Using the periodontal Williams probe
2
Description
Generalized or localized gingivitis.
Timepoint
Evaluation of gingivitis at the beginning of the study and 14 and 28 days after starting the use of dental floss and waterjet.
Method of measurement
Clinical examination and direct observation of gingival changes.
Intervention groups
1
Description
Control group: After scaling patients' teeth, flossing (Mina brand) will be done twice a day for 4 weeks after brushing by people in the control group. Brushing will be done by Modified bass method and twice a day by Hi Dent brand manual toothbrush. The correct method of brushing and using dental floss will be taught by a trained evaluator.
Category
Treatment - Devices
2
Description
Intervention group: Oral irrigator will be used after brushing in the intervention group. The duration of using the device is twice a day for 4 weeks. Brushing will be done by Modified bass method and twice a day by Hi Dent brand manual toothbrush. The correct method of brushing and using oral irrigator will be taught by a trained dental student. Oral irrigator under the registered name (Waterjet mouth washer with the ability to monitor and control the user's hygienic behavior) has been designed and patented by a private Iranian company (registration number: 72641) ( patent number: 103383). Unlike other existing devices based on mechanical mechanisms and piston performance, this device has been designed and manufactured based on electromechanical system and on centrifuge performance. The power of spraying system is between 10 to 70 psi and beats from 100 to 1000 times per minute according to microcontroller programming. The liquid used in the oral irrigator is distilled water. The method of using oral irrigator in the intervention group is taught that the person places the tip of the device at an angle almost perpendicular to the surface of the teeth and supra gingival on the teeth after brushing by trained evaluator.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental university of Mashhad
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Beginning of Vakilabad Ave., In front of Mellat Park ., Mashhad Town Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
info@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour mobarhan
Street address
Beginning of Vakilabad Ave., In front of Mellat park., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
info@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sajjad Niroumand
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 197, Bahar3 Ave.,Bahar Blvd., Quchan Town
City
Quchan
Province
Razavi Khorasan
Postal code
9471644899
Phone
+98 51 4724 2091
Email
niroumands951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nava Naghibi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 225, Resalat 9 Ave., Faramarz Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9185775663
Phone
+98 51 3761 5597
Email
naghibin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sajjad Niroumand
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 197, Bahar3 Ave.,Bahar Blvd., Quchan Town
City
Quchan
Province
Razavi Khorasan
Postal code
9471644899
Phone
+98 51 4724 2091
Email
niroumands951@mums.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about gingival indices will be accessible after indistinguishable to patients.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Researchers related to academic and scientific institutions
Under which criteria data/document could be used
Only academic and scientific researchers will be allowed access to research data and can only be used for statistical analysis.
From where data/document is obtainable
Applicants can receive data if they need the e-mail address of the author responsible for public accountability.
What processes are involved for a request to access data/document
As the request, they will be answered by e-mail from the author responsible for public accountability within a month.