- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04358172
The Effectiveness of a Mobile Application in Educating Partial Denture Wearers
April 21, 2020 updated by: Ho Ting Khee, National University of Malaysia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kuala Lumpur, Malaysia, 50300
- Faculty of Dentistry, National University of Malaysia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mobile app
Participants in this group is educated using the 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.
|
NO_INTERVENTION: 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in knowledge score
Time Frame: Change from baseline knowledge score at 3 months after education
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Plaque Index score
Time Frame: Change from baseline Plaque Index score at 1 month and 3 months after education
|
Participants' oral hygiene
|
Change from baseline Plaque Index score at 1 month and 3 months after education
|
Change in Gingival Index score
Time Frame: Change form baseline Gingival Index score at 1 month and 3 months after education
|
Participants' oral hygiene
|
Change form baseline Gingival Index score at 1 month and 3 months after education
|
Change in Denture plaque score
Time Frame: Change from baseline denture plaque score at 1 month and 3 months after education
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ting Khee Ho, MSc, National University of Malaysia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 29, 2019
Primary Completion (ACTUAL)
November 12, 2019
Study Completion (ACTUAL)
November 12, 2019
Study Registration Dates
First Submitted
April 18, 2020
First Submitted That Met QC Criteria
April 21, 2020
First Posted (ACTUAL)
April 24, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 21, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- JEP-2018-583
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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