The Effectiveness of a Mobile Application in Educating Partial Denture Wearers

Mobile Applications Clinical Trial

Official title:

The Use of Mobile Application as a Tool for Patient Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358172
• Other study ID #: JEP-2018-583
• Status: Completed
• Phase: N/A
• Start date: July 29, 2019
• Est. completion date: November 12, 2019

Study information

• Verified date: April 2020
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomised control trial to evaluate the effect of a mobile application on partial denture wearers's dental knowledge, oral hygiene and denture hygiene. The null hypothesis of the study states that there will be no difference in dental knowledge, oral and denture hygiene among patients educated using the mobile application compared to those educated using the conventional method of verbal instructions accompanied by demonstrations on dental models.

Description:

Partial denture wearers are at higher risk of developing caries and periodontal disease. Thus, providing oral and denture hygiene care instructions after denture delivery is crucial for prevention of oral diseases. A mobile application was developed using the progressive web application technology for chairside education and to serve as a reference material. The effect of the mobile application on patient's dental knowledge compared to the conventional method was evaluated using a knowledge questionnaire administered before and after education. The knowledge scores obtained were analysed using the Two-way mixed ANOVA test. Patients' oral hygiene was assessed by comparing the Silness and Loe Plaque Index and Gingival Index scores before and after education. Denture hygiene was evaluated by comparing the denture plaque score before and after education. Statistical analysis of the Plaque Index, Gingival Index and denture plaque score was done using Mann-Whitney U Test and Friedman Test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 12, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients wearing cobalt-chromium removable partial denture made in the dental laboratory in UKM and delivered by undergraduate students from June 2017 to June 2019 in the Faculty of Dentistry, National University of Malaysia.

2. Patients who own a smart phone with internet access and have been using it within the last six months.

3. Patients aged 25-75 years old.

4. Patients that are literate in English or Malay language.

Exclusion Criteria:

1. Patients who do not wear their removable partial dentures or only wear them occasionally.

2. Patients with a history of denture repair or reline, and those using denture adhesive.

3. Patients with physical or mental disabilities that will impede their ability to perform oral hygiene activities.

4. Patients involved in other oral-health education or oral hygiene maintenance program.

5. Patients who are active smokers.

6. Patients with medical conditions that may affect the gingival health, such as drug-induced gingival hypertrophy or Sjögren syndrome.

Related Conditions & MeSH terms

• Mobile Applications

Intervention

Other:
• 'Oral and Denture Guide' mobile application
'Oral and Denture Guide' mobile application provides evidence-based information about cleaning aids and material for dentures, denture care and oral hygiene instructions.

Locations

Country	Name	City	State
Malaysia	Faculty of Dentistry, National University of Malaysia	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (10)

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Brooke, J. 1996. SUS-A quick and dirty usability scale. In Jordan, Patrick W.,Thomas, B. & Weerdmeester (ed.). Usability Evaluation in Industry, pp. 189-194. London: Taylor & Francis.

Bujang, M. A. & Baharum, N. 2017. A simplified guide to determination of sample size requirements for estimating the value of intraclass correlation coefficient: A review. Archives of Orofacial Sciences The Journal of the School of Dental Sciences 12(1): 1-11.

LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. — View Citation

Majchrzak, T. A., Biørn-Hansen, A. & Grønli, T.-M. 2018. Progressive Web Apps: the definite approach to cross-platform development? Proceedings of the 51st Hawaii International Conference on System Sciences, pp. 5735-5744.

Mohamad Marzuki MF, Yaacob NA, Yaacob NM. Translation, Cross-Cultural Adaptation, and Validation of the Malay Version of the System Usability Scale Questionnaire for the Assessment of Mobile Apps. JMIR Hum Factors. 2018 May 14;5(2):e10308. doi: 10.2196/10308. — View Citation

Nielsen, J. 1994. Heuristic evaluation. In Nielsen, J. & Mack (ed.). Usabiility Inspection Methods., pp. 25-62. New York: John Wiley and Sons.

Sauro, J. & Lewis, J. R. 2016. Standardized usability questionnaires. Quantifying the User Experience, pp. 185-248. Elsevier Inc.

SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. — View Citation

Zaror C, Espinoza-Espinoza G, Atala-Acevedo C, Muñoz-Millán P, Li Y, Clarke K, Onetto J, Díaz J, Hallet K, Manton D, Mariño R. Validation and usability of a mobile phone application for epidemiological surveillance of traumatic dental injuries. Dent Traumatol. 2019 Feb;35(1):33-40. doi: 10.1111/edt.12444. Epub 2018 Oct 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in knowledge score	Participants' knowledge of oral and denture hygiene care. Minimum value:0, Maximum value:20. Higher score better	Change from baseline knowledge score at 3 months after education
Secondary	Change in Plaque Index score	Participants' oral hygiene	Change from baseline Plaque Index score at 1 month and 3 months after education
Secondary	Change in Gingival Index score	Participants' oral hygiene	Change form baseline Gingival Index score at 1 month and 3 months after education
Secondary	Change in Denture plaque score	Participants' denture hygiene. Minimum value:0, Maximum value:4. Lower score better	Change from baseline denture plaque score at 1 month and 3 months after education

External Links

•   Guide on how to built progressive web application
•   Health on the Net Foundation Code of Conduct (HONcode) Guideline to provide reliable and credible health information