- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04307771
Effectiveness of Smart Phone Application in Improving Oral Health Behaviours of Adolescents
September 17, 2020 updated by: Dr.Javeria Nafis, Aga Khan University
Effectiveness of Smart-phone App in Improving Oral-Health Knowledge & Practices Among School Going Adolescents: A Randomized Control Trial
This study would be a first step towards mobile-health associated Sustainable Development Goals by World Health Organization, as there are no mobile-health driven oral health activities in Karachi, Pakistan.
Concurrently, it will help in improving knowledge and practices of adolescents towards general dental hygiene as this age is crucial for the prognosis of newly erupted permanent teeth.
This would help in preventing chronic problems of adulthood.
This will also help in reducing the number of days missed from school, increasing self-confidence of individuals as bad breath has a negative impact on one's self-esteem and confidence, giving a positive sense of aesthetics and will also keep in check over-all body health.Persistent unmaintained dental hygiene also overburdens families due to its high-maintenance outcomes like caries and early tooth loss.
Dental treatment is considered as fourth most expensive treatment in developing countries .
According to recent studies, households of low and middle income countries are at a higher risk of falling below the poverty line due to expenditure on dental problems.
Such a simple intervention making use of modern-day technology would enable adolescents to keep their oral health in check and would prevent them from facing consequences of poor oral health.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Javeria Nafis, Dr
- Phone Number: 923333914773
- Email: jojinafees@hotmail.com
Study Contact Backup
- Name: Saad Shoeb, Dr
- Phone Number: 923362187080
- Email: saadshoeb92@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adolescent of age between 14-19 years
- Having access to an android device at home; either personal or parents'
- Would be able to use the app twice every day- Having access to Wi-Fi at home- for downloading the app.
- Willing to give consent
- participate in the study till the follow-up period.
Exclusion Criteria:
- - Having mixed dentition
- Undergoing orthodontic treatment
- Should have no serious existing gingival or dental problems* that could hinder calculation of plaque or gingival scores
- Should have no serious existing gingival or dental problems* that could hinder routine brushing.
- Taking medications that have effect on gingival/dental health
- Having intrinsic or extrinsic enamel defects/ tooth malformations
- Having more than 1/3rd of the tooth stained due to areca nut chewing, smokeless tobacco (gutkha) chewing or cigarette smoking.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: m-health application
a mobile app designed to send reminders for brushing and give information on maintaining oral health
|
Dental Buddy is a mobile application that has been designed to improve oral hygiene maintenance behaviours in teenagers
Other Names:
|
Other: Leaflet
This is the control arm.
An educational leaflet for maintaining oral hygiene will be given to participants in this arm
|
Dental Buddy is a mobile application that has been designed to improve oral hygiene maintenance behaviours in teenagers
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge scores
Time Frame: 6 weeks
|
Knowledge scores will be assessed by a self-administered questionnaire with maximum score of 30 and minimum of 0. Higher scores mean better knowledge.
|
6 weeks
|
Practice scores
Time Frame: 6 weeks
|
reduction in plaque index scores.
score range 0-6.
score 0 being the best and score 6 being the worst.
Gingival index scores ranging from 0-6, score ) lesser (0) being the best and 6 being the worst.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Shafquat Rozi, Dr, Aga Khan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2021
Primary Completion (Anticipated)
March 1, 2021
Study Completion (Anticipated)
April 30, 2021
Study Registration Dates
First Submitted
March 11, 2020
First Submitted That Met QC Criteria
March 11, 2020
First Posted (Actual)
March 13, 2020
Study Record Updates
Last Update Posted (Actual)
September 18, 2020
Last Update Submitted That Met QC Criteria
September 17, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 3539
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oral Hygiene
-
San Diego State UniversityVista Community ClinicCompleted
-
Virginia Commonwealth UniversityDentaQuest Institute, Inc.WithdrawnOral Hygiene
-
Riyadh Colleges of Dentistry and PharmacyUnknown
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedOral HygieneUnited States
-
Riyadh Colleges of Dentistry and PharmacyUnknown
-
University of BarcelonaCompleted
-
GlaxoSmithKlineCompletedOral HygieneUnited States
Clinical Trials on m-Health application
-
Aga Khan UniversityNot yet recruitingMalnutrition, Child | Malnutrition, InfantPakistan
-
Mayo ClinicRecruitingCardiac RehabilitationUnited States
-
National Defense Medical Center, TaiwanCompletedAnxiety | Acute Myocardial Infarction | Mobile Health | Self-efficacy | Undefined | Cardio-respiratory FitnessTaiwan
-
Duke UniversityPhRMA FoundationCompletedHypertension | Cardiovascular Disease | DiabetesUnited States
-
Sinop UniversityRecruitingMobile Application | Knee ProsthesisTurkey
-
Pennington Biomedical Research CenterSoutheastern Louisiana UniversityCompleted
-
Universidad de GranadaCompleted
-
Peking Union Medical College HospitalUnknownBlood Glucose | Compliance, Patient | Diet Habit | GDM
-
National Center of Cardiology and Internal Medicine...Recruiting