Clinical trial NCT04358172: The Effectiveness of a Mobile Application in Educating Partial Denture Wearers
Official title: The Use of Mobile Application as a Tool for Patient Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobile Applications
Keywords: Progressive web application, Denture care, Oral Hygiene
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 52
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in knowledge score
timeFrame: Change from baseline knowledge score at 3 months after education
Secondary outcomes:
measure: Change in Plaque Index score
timeFrame: Change from baseline Plaque Index score at 1 month and 3 months after education
measure: Change in Gingival Index score
timeFrame: Change form baseline Gingival Index score at 1 month and 3 months after education
measure: Change in Denture plaque score
timeFrame: Change from baseline denture plaque score at 1 month and 3 months after education
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty of Dentistry, National University of Malaysia
Study officials:
affiliation: National University of Malaysia
name: Ting Khee Ho, MSc
role: PRINCIPAL_INVESTIGATOR
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