Designing, implementing and evaluating an educational program to improve the oral and dental health of the elderly in Hamadan city in 2023
Design
A clinical trial with a control group, multi-stage cluster sampling, without blinding and randomized on 577 elderly people.
Settings and conduct
After obtaining the necessary permits, first the list of comprehensive health centers in Hamedan will be received, then three comprehensive health centers in each of the four regions of Hamedan will be randomly selected for study. In the next step, the sample size will be determined according to the number of comprehensive health centers in each of the 4 regions of Hamedan city and the population of elderly people over 60 covered by each center in that region. Then, by visiting each center in person, the elderly are included in the study according to the sample size and based on the entry and exit criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: at least 65 years old and having informed consent
Exclusion criteria: patients with complete edentulism
Intervention groups
Intervention group: use of educational program
Control group: using routine training
Main outcome variables
Behavior: Self-care behaviors in the field of oral health. Community Periodontal Index: Evaluation of periodontal condition based on presence of calculus, gingival bleeding and presence of periodontal pocket. Simplified Oral Hygiene Index: Evaluation of dental debris and calculus based on the involved surfaces of index teeth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230428058016N1
Registration date:2023-06-05, 1402/03/15
Registration timing:registered_while_recruiting
Last update:2023-06-05, 1402/03/15
Update count:0
Registration date
2023-06-05, 1402/03/15
Registrant information
Name
Mahboubeh Babaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3252 0182
Email address
m.babaee74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-21, 1402/02/31
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing, implementing and evaluation an educational program to improve the oral and dental health of the elderly in Hamadan city in 2023
Public title
Effect of educational program on improving the oral and dental health of the elderly
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age of 65 years
Having informed consent
Exclusion criteria:
Patients with complete edentulism
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
577
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this study is a multi-stage cluster. Sampling will be done using a random number table. For this purpose, a list of all comprehensive health centers will be received first, and a two-digit code will be given to each comprehensive health center (codes 01 to 35 for comprehensive health centers). To choose a comprehensive health center, refer to the table of random numbers and select the starting point. The starting point will be done by closing the eyes and placing a finger or the tip of the pen on the table. Then it will move in the direction of the line based on the adjacent two-digit numbers. In this path, two types of numbers are encountered, one of which is smaller than the total number of comprehensive health centers and the other type is larger than the number of comprehensive health centers. Only smaller numbers will be selected for sampling. The selected number is actually the central code that is selected as a sample. Then, the elderly of each center will be included in the study based on having the entry and exit criteria.
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 Hamadan University of medical sciences
Street address
Hamadan University of medical science, Shahid Fahmide Boulevards
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.UMSHA.REC.1402.109
Health conditions studied
1
Description of health condition studied
Oral health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of people who brushed twice a day with a toothpaste containing fluoride
Timepoint
At the beginning of the study and 12 weeks later
Method of measurement
Behavior standard questionnaire
2
Description
Use dental floss at least once a day
Timepoint
At the beginning of the study and 12 weeks later
Method of measurement
Behavior standard questionnaire
3
Description
Mouthwash use
Timepoint
At the beginning of the study and 12 weeks later
Method of measurement
Behavior standard questionnaire
Secondary outcomes
1
Description
Determining the rate of periodontal tissue health of each person
Timepoint
At the beginning of the study and 12 weeks later
Method of measurement
Clinical examination by a dentist
2
Description
Determining the rate of dental debris and calculus in each person
Timepoint
At the beginning of the study and 12 weeks later
Method of measurement
Clinical examination by a dentist
Intervention groups
1
Description
Intervention group:Intervention group: The second intervention group: The training program in this group will include 6 face-to-face training sessions for the elderly during four months. Also, a brochure will be prepared for geriatric nurses, which will provide tips on the importance of oral and dental hygiene and its role in public health, and the goals and implementation of the intervention program. Interventions in the elderly are carried out with the help of support groups. The elderly will be trained in the following areas: the importance of oral and dental hygiene, knowledge of tooth and periodontal structure, awareness of oral and dental diseases (decay and periodontal diseases) and their causes, ways to prevent oral and dental diseases .
Category
Prevention
2
Description
Control group: Receive routine programs and training
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dibaj comprehensive health service center
Full name of responsible person
Mohsen Nowruzi
Street address
Kamal Abad area, Mirzadeh Eshghi Street
City
Hamadan
Province
Hamadan
Postal code
6516764741
Phone
+98 81 3833 1024
Email
m.babaee74@gmail.com
2
Recruitment center
Name of recruitment center
Samii Modares comprehensive health service center
Full name of responsible person
Mohammad Hossein Azimian
Street address
Next to the police station, Modares town
City
Hamadan
Province
Hamadan
Postal code
6517833193
Phone
+98 81 3829 0100
Email
m.babaee74@gmail.com
3
Recruitment center
Name of recruitment center
Sami Ostadan comprehensive health service center
Full name of responsible person
Fatemeh Hesami
Street address
Hakim Street, Murad Bey valley old road, Ostadan town
City
Hamadan
Province
Hamadan
Postal code
6518777181
Phone
+98 81 3824 3300
Email
m.babaee74@gmail.com
4
Recruitment center
Name of recruitment center
Imam Khomeini Comprehensive Health Service Center
Full name of responsible person
Susan Mahtabani
Street address
In front of Ghadir complex, Jihad street, Beheshti town
City
Hamadan
Province
Hamadan
Postal code
6515794755
Phone
+98 81 3262 3367
Email
m.babaee74@gmail.com
5
Recruitment center
Name of recruitment center
Shohada comprehensive health service center
Full name of responsible person
Fariba Asadi
Street address
Takhti street, Imam Khomeini Square
City
Hamadan
Province
Hamadan
Postal code
6515617314
Phone
+98 81 3252 0744
Email
m.babaee74@gmail.com
6
Recruitment center
Name of recruitment center
Imam Sajjad Comprehensive Health Service Center
Full name of responsible person
Zahra Ranjbaran
Street address
Behind the oil depot, Shahid Chitsazian Blvd
City
Hamadan
Province
Hamadan
Postal code
6514764675
Phone
+98 81 3265 3018
Email
m.babaee74@gmail.com
7
Recruitment center
Name of recruitment center
Shahid Karbasian Comprehensive Health Service Center (PA)
Full name of responsible person
Maryam Mansour
Street address
Shahid Yarmtaghlo Alley, At the end of Khizr
City
Hamadan
Province
Hamadan
Postal code
6519654571
Phone
+98 81 3275 5199
Email
m.babaee74@gmail.com
8
Recruitment center
Name of recruitment center
Banoushreifi Comprehensive Health Service Center
Full name of responsible person
Mehdi Amini
Street address
Next to Hijrat High School, Ayatollah Talahi Blvd
City
Hamadan
Province
Hamadan
Postal code
6513663131
Phone
+98 81 3265 1823
Email
m.babaee74@gmail.com
9
Recruitment center
Name of recruitment center
Samii comprehensive health service center in Madani town
Full name of responsible person
Mojtaba Badri
Street address
Block 7,Phase 2, Shahrak Madani
City
Hamadan
Province
Hamadan
Postal code
6513993436
Phone
+98 81 3429 2323
Email
m.babaee74@gmail.com
10
Recruitment center
Name of recruitment center
Farhangian comprehensive health service center
Full name of responsible person
Maryam Lakzadeh
Street address
Student Street, Moalem Square, Phase1, Farhangian town
City
Hamadan
Province
Hamadan
Postal code
6519963449
Phone
+98 81 3254 9033
Email
m.babaee74@gmail.com
11
Recruitment center
Name of recruitment center
Imam Hossein Comprehensive Health Service Center
Full name of responsible person
Mehdi Heydari Karamat
Street address
Friday Alley, Vahdat Blvd, Khizr
City
Hamadan
Province
Hamadan
Postal code
6513719196
Phone
+98 81 3266 0550
Email
m.babaee74@gmail.com
12
Recruitment center
Name of recruitment center
Khatam comprehensive health service center
Full name of responsible person
Zohreh Atri
Street address
Tawheed Street
City
Hamadan
Province
Hamadan
Postal code
6518718886
Phone
+98 81 3422 8028
Email
m.babaee74@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
4th floor, Headquarters of Hamadan University of medical science, Shahid Fahmideh Boulevards
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mahboubeh Babaei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Hamadan university of medical sciences, Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3252 0182
Fax
Email
m.babaee74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahboubeh Babaei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Hamadan university of medical sciences, Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3252 0182
Fax
Email
m.babaee74@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahboubeh Babaei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Hamadan university of medical sciences, Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3252 0182
Fax
Email
m.babaee74@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
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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
People who intend to use the study data for review articles and meta-analysis
From where data/document is obtainable
Mahboubeh Babaei email
What processes are involved for a request to access data/document
After checking the requester's email by Zeinab Mosayebi, if the conditions are met, the data will be sent to them 3 days later.