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The effectiveness of Mobile-based Self-care Application for Oral-dental Hygiene of Pregnant Women on Dental plaque, Gingivitis and White spot lesions

Protocol summary

Study aim
Comparing the effectiveness of mobile-based self-care application for oral-dental hygiene of Pregnant Women on dental plaque, gingivitis and white spot lesions
Design
In this study, 70 pregnant women in two control groups and intervention at three time points, baseline, one month after using the application and three months after using it will be evaluated. The presenting dentist and the dentist evaluating the outcomes and pregnant women are blinded.
Settings and conduct
Dental plaque index, gingivitis and white spot lesions in 70 pregnant women in two control and intervention groups at three time points, baseline, one month after using the application and three months after using the application will be evaluated. In this study, the presenting dentist and the dentist evaluating the outcomes and pregnant women are blinded.
Participants/Inclusion and exclusion criteria
Inclusion - Age between 25 and 35 years - Willingness to participate in the study - Having a smart mobile phone - Ability to work with application program - Gestational age of the second and third trimesters of pregnancy (from the 15th week to the end of delivery) - Pregnant women without tooth decay and gum disease Exclusion - Having mental and physical disability - Having oral and dental diseases - Using drugs that affect the accumulation of dental plaque, such as antibiotics and antibacterial mouthwashes
Intervention groups
Control group: The dentist will present oral-dental hygiene principles to the control group. Also, this group will be given brochures prepared about oral and dental hygiene. Intervention group: people in the intervention group, in addition to receiving the oral-dental hygiene principles and brochures about oral-dental hygiene, receive a mobile-based self-care application.
Main outcome variables
Dental plaque, Gingivitis index, White spot lesions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230624058570N1
Registration date: 2023-07-01, 1402/04/10
Registration timing: prospective

Last update: 2023-07-01, 1402/04/10
Update count: 0
Registration date
2023-07-01, 1402/04/10
Registrant information
Name
Sahar Khenarinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8878 0736
Email address
khenarisahar73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Mobile-based Self-care Application for Oral-dental Hygiene of Pregnant Women on Dental plaque, Gingivitis and White spot lesions
Public title
Effectiveness of Mobile-based Application on Dental plaque, Gingivitis and White spot lesions in Pregnant Women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 25 and 35 years Willingness to participate in the study Having a smart phone Ability to work with applications Gestational age of the second and third trimesters of pregnancy (from the 15th week to the end of delivery) Pregnant women without tooth decay and gum disease
Exclusion criteria:
Having mental and physical disability Having oral and dental diseases Using drugs that affect the accumulation of dental plaque, such as antibiotics and antibacterial mouthwashes
Age
From 25 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The research sample will be 70 pregnant women referring to the oral and dental health unit of the health network covered by Mazandaran University of Medical Sciences. The people of the sample group will be divided into two control groups (35 people) and intervention (35 people) with the randomization tool of the sealed envelope. In this study, the dentist providing the common principles of oral and dental hygiene and the dentist evaluating the results will not know about the presence of each patient in the control and intervention groups. Also, pregnant women will be blinded to grouping.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the dentist providing the common principles of oral and dental hygiene and the dentist evaluating the results will not know about the presence of each patient in the control and intervention groups. Also, pregnant women will be blinded to grouping. Therefore, the present study will be conducted as a double-blind randomized clinical trial.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-06-12, 1402/03/22
Ethics committee reference number
IR.IUMS.REC.1402.197

Health conditions studied

1

Description of health condition studied
Oral-Dental Hygiene
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Dental plaque index
Timepoint
At the beginning of the study (before the intervention), one month after using the application and three months after using the application
Method of measurement
Plaque disclosing tablet and Plaque ontrol record (O'Leary index)

2

Description
Gingival Index (GI)
Timepoint
At the beginning of the study (before the intervention), one month after using the application and three months after using the application
Method of measurement
Loe and sillness index

3

Description
White spot lesions
Timepoint
At the beginning of the study (before the intervention), one month after using the application and three months after using the application
Method of measurement
Visual examination method

Secondary outcomes

empty

Intervention groups

1

Description
Control group: People in the control group will receive the oral-dental hygiene principles orally by the dentist. In addition, brochures prepared about oral-dental hygiene will be given to the control group.
Category
Prevention

2

Description
Intervention group: Pregnant women in the intervention group, in addition to receiving oral-dental hygiene principles and oral-dental hygiene brochures, will also receive a mobile-based self-care application.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Oral and dental hygiene unit of health network covered by Mazandaran University of Medical Sciences
Full name of responsible person
Farhad Gholami
Street address
Sari, Joibar Three Roads, the beginning of Vali Asr Highway (Aj), Mazandaran University of Medical Sciences and Health Services
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
khenarisahar73@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abdolreza Pazouki
Street address
Shahid Hemet Highway, next to Milad Tower, Iran University of Medical Sciences, Central Headquarters Building, sixth floor
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8862 2600
Email
apazouki@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farahnaz Sadoughi
Position
Professor of Health Information Management
Latest degree
Ph.D.
Other areas of specialty/work
Health Information Management
Street address
Tehran, Valiasr St. (AJ), above Mirdamad, Rashid Yasmi St., Faculty of Medical Information and Management
City
Tehran
Province
Tehran
Postal code
02188883334
Phone
+98 21 8879 4301
Email
sadoughi.f@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farahnaz Sadoughi
Position
Professor of Health Information Management
Latest degree
Ph.D.
Other areas of specialty/work
Health Information Management
Street address
Tehran, Valiasr St. (AJ), above Mirdamad, Rashid Yasmi St., Faculty of Medical Information and Management
City
Tehran
Province
Tehran
Postal code
02188883334
Phone
+98 21 8879 4301
Email
sadoughi.f@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sahar Khenarinezhad
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health information management
Street address
School of Health Management and Information Sciences, No. 4, Rashid Yasemi St. Vali –e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
02188883334
Phone
+98 21 8878 0736
Fax
Email
khenarisahar73@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of a systematic review along with the oral-dental health application and the effect of the mobile application on dental plaque, gingivitis index and white spot lesions in pregnant women.
When the data will become available and for how long
از سال 1400
To whom data/document is available
Researchers interested in the subject of this study
Under which criteria data/document could be used
For use in selecting or designing a mobile -based self-care application on oral-dental hygiene for Pregnant Women
From where data/document is obtainable
sadoughi.f@gmail.com
What processes are involved for a request to access data/document
After receiving the data request email, the data will be sent to the researcher within 1 week.
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