NCT03390452

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
362

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

2 active sites

Status
completed

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

August 11, 2016

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

August 11, 2016

Last Update Submit

February 10, 2021

Conditions

Keywords

mHealthOral HealthPrimary School ChildrenMobile Phone Messaging

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Mobile Phone Messaging

Control

NO INTERVENTION

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.

Interventions

Parents of primary school children will receive "Mobile Phone Messages" regarding their children's oral hygiene maintenance and their positive dietary habits.

Intervention

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ashfaq Ahmed Khawajakhail

Quetta, Balochistan, 87300, Pakistan

Location

Dental Section, Sandman Provincial Hospital Quetta

Quetta, Balochistan, 87300, Pakistan

Location

Related Publications (15)

  • Petersen PE. The World Oral Health Report 2003: continuous improvement of oral health in the 21st century--the approach of the WHO Global Oral Health Programme. Community Dent Oral Epidemiol. 2003 Dec;31 Suppl 1:3-23. doi: 10.1046/j..2003.com122.x.

    PMID: 15015736BACKGROUND
  • Higgs ES, Goldberg AB, Labrique AB, Cook SH, Schmid C, Cole CF, Obregon RA. Understanding the role of mHealth and other media interventions for behavior change to enhance child survival and development in low- and middle-income countries: an evidence review. J Health Commun. 2014;19 Suppl 1(sup1):164-89. doi: 10.1080/10810730.2014.929763.

    PMID: 25207452BACKGROUND
  • Kay E, Locker D. A systematic review of the effectiveness of health promotion aimed at improving oral health. Community Dent Health. 1998 Sep;15(3):132-44.

    PMID: 10645682BACKGROUND
  • Ben-Zeev D, Schueller SM, Begale M, Duffecy J, Kane JM, Mohr DC. Strategies for mHealth research: lessons from 3 mobile intervention studies. Adm Policy Ment Health. 2015 Mar;42(2):157-67. doi: 10.1007/s10488-014-0556-2.

    PMID: 24824311BACKGROUND
  • Watt RG. Strategies and approaches in oral disease prevention and health promotion. Bull World Health Organ. 2005 Sep;83(9):711-8. Epub 2005 Sep 30.

    PMID: 16211164BACKGROUND
  • Haleem A, Siddiqui MI, Khan AA. School-based strategies for oral health education of adolescents--a cluster randomized controlled trial. BMC Oral Health. 2012 Dec 18;12:54. doi: 10.1186/1472-6831-12-54.

    PMID: 23249443BACKGROUND
  • Saied-Moallemi Z, Virtanen JI, Vehkalahti MM, Tehranchi A, Murtomaa H. School-based intervention to promote preadolescents' gingival health: a community trial. Community Dent Oral Epidemiol. 2009 Dec;37(6):518-26. doi: 10.1111/j.1600-0528.2009.00491.x. Epub 2009 Aug 20.

    PMID: 19694774BACKGROUND
  • da Costa TM, Barbosa BJ, Gomes e Costa DA, Sigulem D, de Fatima Marin H, Filho AC, Pisa IT. Results of a randomized controlled trial to assess the effects of a mobile SMS-based intervention on treatment adherence in HIV/AIDS-infected Brazilian women and impressions and satisfaction with respect to incoming messages. Int J Med Inform. 2012 Apr;81(4):257-69. doi: 10.1016/j.ijmedinf.2011.10.002. Epub 2012 Jan 31.

    PMID: 22296762BACKGROUND
  • Park LG, Howie-Esquivel J, Dracup K. A quantitative systematic review of the efficacy of mobile phone interventions to improve medication adherence. J Adv Nurs. 2014 Sep;70(9):1932-1953. doi: 10.1111/jan.12400. Epub 2014 Apr 1.

    PMID: 24689978BACKGROUND
  • Nyandindi U, Palin-Palokas T, Milen A, Robison V, Kombe N, Mwakasagule S. Participation, willingness and abilities of school-teachers in oral health education in Tanzania. Community Dent Health. 1994 Jun;11(2):101-4.

    PMID: 8044706BACKGROUND
  • de Silva-Sanigorski A, Ashbolt R, Green J, Calache H, Keith B, Riggs E, Waters E. Parental self-efficacy and oral health-related knowledge are associated with parent and child oral health behaviors and self-reported oral health status. Community Dent Oral Epidemiol. 2013 Aug;41(4):345-52. doi: 10.1111/cdoe.12019. Epub 2012 Nov 17.

    PMID: 23157162BACKGROUND
  • Sharma R, Hebbal M, Ankola AV, Murugabupathy V. Mobile-phone text messaging (SMS) for providing oral health education to mothers of preschool children in Belgaum City. J Telemed Telecare. 2011;17(8):432-6. doi: 10.1258/jtt.2011.110416. Epub 2011 Oct 24.

    PMID: 22025742BACKGROUND
  • Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for health: a systematic review of reviews. Annu Rev Public Health. 2015 Mar 18;36:393-415. doi: 10.1146/annurev-publhealth-031914-122855.

    PMID: 25785892BACKGROUND
  • Castilho AR, Mialhe FL, Barbosa Tde S, Puppin-Rontani RM. Influence of family environment on children's oral health: a systematic review. J Pediatr (Rio J). 2013 Mar-Apr;89(2):116-23. doi: 10.1016/j.jped.2013.03.014.

    PMID: 23642420BACKGROUND
  • Folayan MO, Kolawole KA, Oyedele T, Chukwumah NM, Onyejaka N, Agbaje H, Oziegbe EO, Oshomoji OV. Association between knowledge of caries preventive practices, preventive oral health habits of parents and children and caries experience in children resident in sub-urban Nigeria. BMC Oral Health. 2014 Dec 16;14:156. doi: 10.1186/1472-6831-14-156.

    PMID: 25516332BACKGROUND

Study Officials

  • Ashfaq A Khawajakhail, MPH

    Health services Academy, Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Fellow (Public Health)

Study Record Dates

First Submitted

August 11, 2016

First Posted

January 4, 2018

Study Start

September 1, 2018

Primary Completion

April 30, 2019

Study Completion

October 30, 2019

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations