Comparison of the effect of different plaque control training methods on the periodontal status of patients referred to the Periodontology Department of Zanjan University of Medical Sciences in 2001
Design
After completing the file and recording the basic information, the plaque index and gingival index of the patients were measured. Then the patients were randomly divided into 3 groups so that each group had a different plaque control training method. The patients were examined in terms of periodontal indicators and the presence of caries and group matching was done in all three groups. People referring to the clinic department of Zanjan University of Medical Sciences, after checking the entry criteria, were included in the study and were randomly assigned to three groups. Random block method with equal block volume was used. Randomized blocks were generated in the R software environment.
Two weeks after receiving the training, the patients were invited to the faculty for a review period, so that the specified indices were measured again and their results were compared through statistical analysis.
Settings and conduct
Zanjan University of Medical Sciences
Participants/Inclusion and exclusion criteria
All patients who refer to the perioperative department to receive the first phase treatments.
Entry criteria:
Patients with periodontal disease (gingivitis or periodontitis) referred to the periodontal department of the Faculty of Dentistry
Having informed consent to participate in the study
Being between 18 and 50 years old (in order to take the meetings seriously and also to be able to understand the contents)
Intervention groups
The first group of video training, the second group of training with brochures and the third group of training in person (with replicas)
Main outcome variables
Periodontal status of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180516039682N4
Registration date:2023-08-08, 1402/05/17
Registration timing:prospective
Last update:2023-08-08, 1402/05/17
Update count:0
Registration date
2023-08-08, 1402/05/17
Registrant information
Name
Raheleh Akhavan rasoolzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8101
Email address
r.rasoolzadeh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-20, 1402/06/29
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of different plaque control training methods on the periodontal status of patients referred to the Periodontology Department
Public title
different plaque control training methods and the periodontal status of patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with periodontal disease (gingivitis or periodontitis) referred to the Periodontology Department of the Faculty of Dentistry.
Informed consent to participate in the study
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done using Excel software. The letters A, B and C are used to represent each group. According to the sample number of 30 people in each group, the letter A is entered 30 times, the letter B 30 times, and the letter C 30 times in a column (we will have a column containing 90 rows with the values of A, B, and C). Then, in the second column, we generate a random number using the RAND function. We sort the data based on the column values containing random numbers (ascending or descending). With this sorting, the placement order of A, B and C is also changed and placed randomly. According to the order of appearance of A, B and C, the samples are assigned to three groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Mahdavi Ave
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2023-02-01, 1401/11/12
Ethics committee reference number
IR.ZUMS.REC.1401.321
Health conditions studied
1
Description of health condition studied
periodontal
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plaque control record
Timepoint
At the beginning of the study and two weeks after the end of the intervention
Method of measurement
Oral examination
2
Description
Gingivial index
Timepoint
At the beginning of the study and two weeks after the end of the intervention
Method of measurement
Oral examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Video tutorial
Category
Behavior
2
Description
Intervention group: Training with brochures
Category
Behavior
3
Description
Intervention group: face-to-face training (with maquette)
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic department of Zanjan University of Medical Sciences Faculty of Dentistry
Full name of responsible person
Roya karami
Street address
Mahdavi Ave
City
zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3314 8100
Email
dentist@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vice President of Research
Street address
Mahdavi Ave
City
zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8000
Email
info@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Raheleh akhavan Rasoolzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mahdavi Ave
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
024-331481001
Email
R.Rasoolzadeh@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Raheleh Akhavan Rasoulzadeh
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mahdavi Ave
City
زنجان
Province
Zanjan
Postal code
4513956184
Phone
024-331481001
Email
R.Rasoolzadeh@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Raheleh Akhavan Rasoulzadeh
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mahdavi Ave
City
zanjan
Province
Zanjan
Postal code
4513956184
Phone
024-331481001
Email
R.Rasoolzadeh@zums.ac.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
The information entered in the execution method will be accessible in the same way and with the existing coding
When the data will become available and for how long
One month after the publication of the article
To whom data/document is available
For all applicants
Under which criteria data/document could be used
Any use of data with reference to the source
From where data/document is obtainable
Email to the author or visit the faculty
What processes are involved for a request to access data/document