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CompletedNCT03390452Updated Feb 11, 2021

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

An interventional study of Mobile Phone Messaging in Oral Hygiene and Dental Plaque Induced Gingivitis, sponsored by Health Services Academy, Islamabad, Pakistan. Completed at 2 sites in Pakistan. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by Health Services Academy, Islamabad, Pakistan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
362
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Oral Hygiene
  • Dental Plaque Induced Gingivitis

Keywords

  • mHealth
  • Oral Health
  • Primary School Children
  • Mobile Phone Messaging
03

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
362 participants (actual)

Study arms

  • Experimental
    Intervention

    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

  • No intervention
    Control

    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

  • BehavioralMobile Phone Messaging

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

05

What researchers measure

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

    Time frame: 6 months

06

Study locations

2 sites
  • Ashfaq Ahmed Khawajakhail
    Quetta, Balochistan 87300, Pakistan
  • Dental Section, Sandman Provincial Hospital Quetta
    Quetta, Balochistan 87300, Pakistan
07

References and documents

Publications

  • 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. PubMed 15015736 ↗
  • 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. PubMed 25207452 ↗
  • 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. PubMed 10645682 ↗
  • 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. PubMed 24824311 ↗
  • 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. PubMed 16211164 ↗
  • 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. PubMed 23249443 ↗
  • 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. PubMed 19694774 ↗
  • 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. PubMed 22296762 ↗
  • 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. PubMed 24689978 ↗
  • 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. PubMed 8044706 ↗
  • 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. PubMed 23157162 ↗
  • 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. PubMed 22025742 ↗
  • 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. PubMed 25785892 ↗
  • 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. PubMed 23642420 ↗
  • 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. Erratum In: BMC Oral Health. 2015 May 20;15:62. doi: 10.1186/s12903-015-0044-4.. Osho, Olusegun V [corrected to Oshomoji, Olusegun V]; Chukumah, Nneka M [corrected to Chukwumah, Nneka M]. PubMed 25516332 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03390452
Lead sponsor
Health Services Academy, Islamabad, Pakistan
Responsible party
Dr. Ashfaq Ahmed Khawaja Khail (PhD Fellow (Public Health), Health Services Academy, Islamabad, Pakistan) — Principal investigator
First posted
Jan 4, 2018
Start date
Sep 1, 2018
Primary completion
Apr 30, 2019
Completion
Oct 30, 2019
Last update
Feb 11, 2021

Study contacts

Ashfaq A Khawajakhail, MPH
principal investigator · Health services Academy, Islamabad

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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