Oral HygieneNCT04307771
Effectiveness of Smart Phone Application in Improving Oral Health Behaviours of Adolescents
A study testing m-Health application in people with Oral Hygiene, run by Aga Khan University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- m-Health application
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- - 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Oral Hygiene
- Being tested
- m-Health application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
m-Health applicationBehavioural
Also called Dental Buddy
Dental Buddy is a mobile application that has been designed to improve oral hygiene maintenance behaviours in teenagers
| Study group | Role | What they receive |
|---|---|---|
| m-health application | Experimental | a mobile app designed to send reminders for brushing and give information on maintaining oral health Receives: Behavioral: m-Health application |
| Leaflet | Other | This is the control arm. An educational leaflet for maintaining oral hygiene will be given to participants in this arm Receives: Behavioral: m-Health application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge scores
Knowledge scores will be assessed by a self-administered questionnaire with maximum score of 30 and minimum of 0. Higher scores mean better knowledge.
Measured: 6 weeks
Practice scores
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study startFeb 2021 (estimated)
- Primary completionMar 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Javeria Nafis, Aga Khan University
- Investigators
- Shafquat Rozi, Dr, Study director, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307771
- Sponsor's protocol ID
- 3539
- Status last verified
- Sep 2020
- First submitted
- 11 Mar 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Smart-phone App in Improving Oral-Health Knowledge & Practices Among School Going Adolescents: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04307771
- Acronym / sponsor ID
- 3539
- Conditions
- Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| m-health application | Experimental | Behavioral: m-Health applicationa mobile app designed to send reminders for brushing and give information on maintaining oral health |
| Leaflet | Other | Behavioral: m-Health applicationThis is the control arm. An educational leaflet for maintaining oral hygiene will be given to participants in this arm |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| m-Health applicationAlso: Dental BuddyDental Buddy is a mobile application that has been designed to improve oral hygiene maintenance behaviours in teenagers | Behavioural | Leaflet, m-health application |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shafquat Rozi, Dr study director
Aga Khan University
Questions about this trial
What is this clinical trial studying?
A study testing m-Health application in people with Oral Hygiene, run by Aga Khan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javeria Nafis, Dr (923333914773, jojinafees@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge scores (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.