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Mobile Phone Messaging To Improve Oral Hygiene Among Primary School Children in Pakistan

Primary Purpose

Oral Hygiene, Dental Plaque Induced Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mobile Phone Messaging
Sponsored by
Health Services Academy, Islamabad, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Hygiene focused on measuring mHealth, Oral Health, Primary School Children, Mobile Phone Messaging

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • School children enrolled in primary schools (public and private) in Quetta city.
  • Primary School children who are permanent residents of Quetta

Exclusion Criteria:

  • Primary School children whose parents/caregivers do not own a mobile phone
  • Primary School children having orthodontic or any other mouth appliance for example Braces etc.
  • Primary School children who have been diagnosed for a systemic illness e.g. Blood disorders or, Diabetes
  • Primary School children who are absent during the time of data collection

Sites / Locations

  • Ashfaq Ahmed Khawajakhail
  • Dental Section, Sandman Provincial Hospital Quetta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

The parents will receive "Mobile phone messages" about oral hygiene and healthy dieting of their children through teachers. The message format will be text and images, depending upon the education/ literacy level of the parents. Parents will be reminded and information reinforced, at frequent intervals for a period of six months. Oral hygiene of School children will be assessed before intervention, after 6 months interval

The primary school children in the control group will not receive any intervention via their parents or teachers (in-active controls) but will be observed on selected outcome measures for baseline data, then at six month interval to compare for differences (if any) with intervention group.

Outcomes

Primary Outcome Measures

Change in the Oral Hygiene Index Scores
Oral hygiene will be measured through "Simplified Oral Hygiene Index" (OHI-S). Each participant will undergo a dental examination in the school by a trained group of examiners (Qualified Dentists). The WHO recommended protocols for Dental examinations will be followed in assessing outcome measure. Simplified Oral Hygiene Index (OHI-S) was developed by Greene and Vermillion in 1964. The OHI-S has two components, the Debris Index (DI) and the Calculus Index (CI). Each of these indexes is based on numerical determinations representing the amount of debris or calculus found on the pre-selected tooth surfaces. For each individual, the debris scores are totaled and divided by the number of surfaces scored. The average individual or group debris and calculus scores are combined to obtain the "Simplified Oral Hygiene Index". The group baseline scores for both the arms will be compared with the post-intervention scores to observe the change (if any) to conclude the study results

Secondary Outcome Measures

Full Information

First Posted
August 11, 2016
Last Updated
February 10, 2021
Sponsor
Health Services Academy, Islamabad, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT03390452
Brief Title
Mobile Phone Messaging To Improve Oral Hygiene Among Primary School Children in Pakistan
Official Title
Mobile Phone Messaging to Parents: To Improve Oral Hygiene Among Primary School Children In Quetta, Pakistan
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Services Academy, Islamabad, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Oral health is an important component of general health and oral cavity acts as a mirror to the health of individuals and communities. Inadequate focus on primary prevention of oral diseases, poses a sizeable challenge for numerous countries, especially low and middle income countries. Mobile phone technology is relatively new and its successes in chronic disease is well documented but there is little evidence available in its use for improving oral health and dietary habits of children. This will be a Pilot Randomized Control Trial (RCT) . It will be conducted in public and private sector schools of Quetta city, Pakistan. Study will comprise of intervention and a control arm. Duration of intervention is 6 months. In the intervention group, study participants will be the parents. School teachers will send oral health education and reminder messages on frequent intervals to educate children's parents on oral hygiene and reinforce their behaviors to improve their child oral health. The primary school children in the control group will not receive any intervention
Detailed Description
Oral health is a vital part of general health and oral cavity is considered as a mirror to the health of individuals and communities. Poor oral health has a great impact on general health and several oral conditions are found to be associated with heart and lung diseases, diabetes, low-birth-weight and premature births. Oral conditions also affect the quality of life through affecting speech, eating, education, facial appearance, confidence and social interaction. Schools settings are important to reach children. School going age is considered as a receptive and influential phase in an individual's life during which lifelong health related behaviors, attitudes and beliefs are developed. Parents have great role in improving their children's oral health. They can influence their children oral health and behaviors and can provide a supportive environment to their children at home in terms of oral hygiene and diet and prevention of risk factors for oral diseases. Mobile phone text messaging is a powerful tool for changing behaviors as these are common, available, low-cost, and quick.(30) Text messaging can be utilized in reducing the global burden of diseases by promoting healthy behaviors and supporting disease prevention The main objective of this study is to assess the use of mobile phone (health) messages to Parents of public and private sector primary school children to improve their oral hygiene status This study will be a Pilot Randomized Control Trial (RCT), comprising of two arms Intervention and Control arm. In the intervention groups study participants will be the school teachers, parents and primary school children. School teachers will be provided messages (designed by Dental Public Health Professionals or adopted from other sources) through the researcher himself. The teachers will then form groups to send oral health education and reminder messages on frequent intervals to educate children's parents on oral hygiene and reinforce their behaviors to improve their child oral health. Parents will receive mobile phone messages about oral hygiene and healthy dieting of their children by the teachers. The message format will be text and images, depending upon the education/ literacy level of the parents. Parents will be reminded and information reinforced, at frequent intervals for a period of six months. School Children will be evaluated on their oral hygiene through gingival bleeding and plaque scores at the start of intervention, after three months and at the end of intervention i.e six months. The primary school children in the control group will not receive any intervention via their parents or teachers (in-active controls) but will be observed on selected outcome measures for baseline data, then at 3 months and at six month interval to compare for differences (if any) with intervention group. The total duration of this study is two years (2017 to 2018) including the intervention which will be of six months duration. After six months of start of intervention; both the intervention group and the control group will be assessed and evaluated on the primary outcome i.e. Oral hygiene measured through "Oral Hygiene Index" which is a standardized index for assessing oral hygiene and recommended by World health Organization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Hygiene, Dental Plaque Induced Gingivitis
Keywords
mHealth, Oral Health, Primary School Children, Mobile Phone Messaging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The parents will receive "Mobile phone messages" about oral hygiene and healthy dieting of their children through teachers. The message format will be text and images, depending upon the education/ literacy level of the parents. Parents will be reminded and information reinforced, at frequent intervals for a period of six months. Oral hygiene of School children will be assessed before intervention, after 6 months interval
Arm Title
Control
Arm Type
No Intervention
Arm Description
The primary school children in the control group will not receive any intervention via their parents or teachers (in-active controls) but will be observed on selected outcome measures for baseline data, then at six month interval to compare for differences (if any) with intervention group.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Phone Messaging
Intervention Description
Parents of primary school children will receive "Mobile Phone Messages" regarding their children's oral hygiene maintenance and their positive dietary habits.
Primary Outcome Measure Information:
Title
Change in the Oral Hygiene Index Scores
Description
Oral hygiene will be measured through "Simplified Oral Hygiene Index" (OHI-S). Each participant will undergo a dental examination in the school by a trained group of examiners (Qualified Dentists). The WHO recommended protocols for Dental examinations will be followed in assessing outcome measure. Simplified Oral Hygiene Index (OHI-S) was developed by Greene and Vermillion in 1964. The OHI-S has two components, the Debris Index (DI) and the Calculus Index (CI). Each of these indexes is based on numerical determinations representing the amount of debris or calculus found on the pre-selected tooth surfaces. For each individual, the debris scores are totaled and divided by the number of surfaces scored. The average individual or group debris and calculus scores are combined to obtain the "Simplified Oral Hygiene Index". The group baseline scores for both the arms will be compared with the post-intervention scores to observe the change (if any) to conclude the study results
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: School children enrolled in primary schools (public and private) in Quetta city. Primary School children who are permanent residents of Quetta Exclusion Criteria: Primary School children whose parents/caregivers do not own a mobile phone Primary School children having orthodontic or any other mouth appliance for example Braces etc. Primary School children who have been diagnosed for a systemic illness e.g. Blood disorders or, Diabetes Primary School children who are absent during the time of data collection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashfaq A Khawajakhail, MPH
Organizational Affiliation
Health services Academy, Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashfaq Ahmed Khawajakhail
City
Quetta
State/Province
Balochistan
ZIP/Postal Code
87300
Country
Pakistan
Facility Name
Dental Section, Sandman Provincial Hospital Quetta
City
Quetta
State/Province
Balochistan
ZIP/Postal Code
87300
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Mobile Phone Messaging To Improve Oral Hygiene Among Primary School Children in Pakistan

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