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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03390452
Other study ID # 2212-HSA/Ph.D-2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date October 30, 2019

Study information

Verified date February 2021
Source Health Services Academy, Islamabad, Pakistan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 362
Est. completion date October 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 12 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Pakistan Ashfaq Ahmed Khawajakhail Quetta Balochistan
Pakistan Dental Section, Sandman Provincial Hospital Quetta Quetta Balochistan

Sponsors (1)

Lead Sponsor Collaborator
Health Services Academy, Islamabad, Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (15)

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. — View Citation

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. Review. — View Citation

da Costa TM, Barbosa BJ, Gomes e Costa DA, Sigulem D, de Fátima 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. — View Citation

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. — View Citation

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;15:62. Osho, Olusegun V [corrected to Oshomoji, Olusegun V]; Chukumah, Nneka M [corrected to Chukwumah, Nneka M]. — View Citation

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. — View Citation

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. Review. — View Citation

Higgs ES, Goldberg AB, Labrique AB, Cook SH, Schmid C, Cole CF, Obregón 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 1:164-89. doi: 10.1080/10810730.2014.929763. Review. — View Citation

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. — View Citation

Nyandindi U, Palin-Palokas T, Milén 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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