NCT04358172

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 29, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 18, 2020

Last Update Submit

April 21, 2020

Conditions

Mobile Applications

Keywords

Progressive web application, Denture care, Oral Hygiene

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Plaque Index score

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

  • Change in Gingival Index score

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

  • Change in Denture plaque score

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

Study Arms (2)

Mobile app

EXPERIMENTAL

Participants in this group is educated using the mobile application

Other: 'Oral and Denture Guide' mobile application

Control

NO INTERVENTION

Participants 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)

Interventions

'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.

Mobile app

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, National University of Malaysia

Kuala Lumpur, 50300, Malaysia

Location

Related Publications (10)

  • 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.

    BACKGROUND

  • 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.

    PMID: 30248238BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 29759955BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 14158464BACKGROUND

  • 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.

    PMID: 14121956BACKGROUND

  • 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.

    PMID: 6951034BACKGROUND

Related Links

Study Officials

  • Ting Khee Ho, MSc

    National University of Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The clinician who check the oral index is masked with the group of subjects
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer and Prosthodontist

Study Record Dates

First Submitted

April 18, 2020

First Posted

April 24, 2020

Study Start

July 29, 2019

Primary Completion

November 12, 2019

Study Completion

November 12, 2019

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)