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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Malaysia
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Mobile app
Participants in this group is educated using the mobile application
Other: '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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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