The Effectiveness of a Mobile Application in Educating Partial Denture Wearers

NCT ID: NCT04358172

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-29

Study Completion Date

2019-11-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mobile Applications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The clinician who check the oral index is masked with the group of subjects

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mobile app

Participants in this group is educated using the mobile application

Group Type EXPERIMENTAL

'Oral and Denture Guide' mobile application

Intervention Type OTHER

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

Control

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

'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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ho Ting Khee

Lecturer and Prosthodontist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ting Khee Ho, MSc

Role: PRINCIPAL_INVESTIGATOR

National University of Malaysia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, National University of Malaysia

Kuala Lumpur, , Malaysia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Malaysia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 30248238 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 29759955 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 14158464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14121956 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6951034 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JEP-2018-583

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.