NCT04307771

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

28 days

First QC Date

March 11, 2020

Last Update Submit

September 17, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 weeks

Study Arms (2)

m-health application

EXPERIMENTAL

a mobile app designed to send reminders for brushing and give information on maintaining oral health

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

Behavioral: m-Health application

Interventions

Dental Buddy is a mobile application that has been designed to improve oral hygiene maintenance behaviours in teenagers

Also known as: Dental Buddy
Leafletm-health application

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Shafquat Rozi, Dr

    Aga Khan University

    STUDY DIRECTOR

Central Study Contacts

Javeria Nafis, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate Student, Department of Community Health Sciences, Principal Investigator

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 13, 2020

Study Start

February 1, 2021

Primary Completion

March 1, 2021

Study Completion

April 30, 2021

Last Updated

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share