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Mobile ApplicationsNCT04358172

The Effectiveness of a Mobile Application in Educating Partial Denture Wearers

A study testing 'Oral and Denture Guide' mobile application in people with Mobile Applications, run by National University of Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 25 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Mobile Applications
What is being tested?
'Oral and Denture Guide' mobile application
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteMalaysia
Study dates
29 Jul 2019to 12 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Patients who own a smart phone with internet access and have been using it within the last six months.
  • Patients aged 25-75 years old.
  • Patients that are literate in English or Malay language.

Who cannot join

  • Patients who do not wear their removable partial dentures or only wear them occasionally.
  • Patients with a history of denture repair or reline, and those using denture adhesive.
  • Patients with physical or mental disabilities that will impede their ability to perform oral hygiene activities.
  • Patients involved in other oral-health education or oral hygiene maintenance program.
  • Patients who are active smokers.
  • Patients with medical conditions that may affect the gingival health, such as drug-induced gingival hypertrophy or Sjögren syndrome.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Faculty of Dentistry, National University of Malaysia

    Kuala Lumpur, 50300

Other trials in Malaysia

About this study

Official title: The Use of Mobile Application as a Tool for Patient Education

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.

Read the detailed 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.

Being tested
'Oral and Denture Guide' mobile application
Keywords
Progressive web application, Denture care, Oral Hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 'Oral and Denture Guide' mobile applicationOther

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

Study groups in NCT04358172
Study groupRoleWhat they receive
Mobile appExperimentalParticipants in this group is educated using the mobile application
Receives: Other: 'Oral and Denture Guide' mobile application
ControlNo interventionParticipants in this group is educated using the conventional method practised in the Faculty of Dentistry, National University of Malaysia (verbal instructions accompanied by demonstrations on dental models)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in knowledge score

    Participants' knowledge of oral and denture hygiene care. Minimum value:0, Maximum value:20. Higher score better

    Measured: Change from baseline knowledge score at 3 months after education

Secondary outcomes (3)

  1. Change in Plaque Index score

    Participants' oral hygiene

    Measured: Change from baseline Plaque Index score at 1 month and 3 months after education

  2. Change in Gingival Index score

    Participants' oral hygiene

    Measured: Change form baseline Gingival Index score at 1 month and 3 months after education

  3. Change in Denture plaque score

    Participants' denture hygiene. Minimum value:0, Maximum value:4. Lower score better

    Measured: Change from baseline denture plaque score at 1 month and 3 months after education

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start29 Jul 2019
  3. Primary completion12 Nov 2019
  4. Study completion12 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly allocated into the intervention group (educated using mobile application) and control group (educated using verbal instructions accompanied by demonstrations on dental models)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04358172
Sponsor's protocol ID
JEP-2018-583
Status last verified
Apr 2020
First submitted
18 Apr 2020
Last updated
24 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • Zaror C, Espinoza-Espinoza G, Atala-Acevedo C, Munoz-Millan P, Li Y, Clarke K, Onetto J, Diaz J, Hallet K, Manton D, Marino 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.

    PubMed 30248238

  • 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.

  • 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.

  • 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.

    PubMed 29759955

  • 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.

  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

    PubMed 14158464

  • LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

    PubMed 14121956

  • Augsburger RH, Elahi JM. Evaluation of seven proprietary denture cleansers. J Prosthet Dent. 1982 Apr;47(4):356-9. doi: 10.1016/s0022-3913(82)80079-6. No abstract available.

    PubMed 6951034

Questions about this trial

What is this clinical trial studying?

A study testing 'Oral and Denture Guide' mobile application in people with Mobile Applications, run by National University of Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in knowledge score (time frame: Change from baseline knowledge score at 3 months after education). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04358172, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020; AzTrials last refreshed its copy on 29 Oct 2026.

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