Mobile application-based support for treatment of patients with gum disease
| ISRCTN | ISRCTN12409366 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12409366 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 091241221 |
| Sponsor | Universitas Indonesia |
| Funder | Kementerian Pendidikan, Kebudayaan, Riset, dan Teknologi |
- Submission date
- 21/02/2024
- Registration date
- 28/02/2024
- Last edited
- 08/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Encouraging patients to effectively remove plaque from above the gumline and control factors that contribute to oral disease requires them to understand how to maintain good oral hygiene. This study aims to assess the effects of using a mobile application to help manage gingivitis (gum inflammation) and periodontitis (serious gum infection).
Who can participate?
Women aged between 35 and 55 years with either gingivitis or periodontitis.
What does the study involve?
Participants are randomly allocated to either the control group (plaque removal and dental health education) or the test group (plaque removal and dental health education + mobile application). The test group participants are instructed to download and install mobile apps. For every visit, clinical periodontal parameters are recorded and displayed inside the app to ensure that the participants are aware of whether their periodontal condition has improved or deteriorated. Additionally, the app serves as a daily dental hygiene reminder for users as well as a constant source of education and motivation for periodontal health maintenance. Instructions on how to perform the proper way of brushing and the use of complimentary dental hygiene tools, notably interdental brushes and dental floss, are given simultaneously with the daily reminder sent for users through the app, twice a day (every morning and night). Moreover, dental health education is given to users three times a week in the form of interactive posters. Clinical parameters (e.g. gum bleeding), cognitive scores and a checklist of oral hygiene procedures are assessed at 1 and 3 months after the intervention.
What are the possible benefits and risks of participating?
The researchers expected improvement in clinical parameters, cognitive, and psychomotor aspects. There were no side effects or adverse events.
Where is the study run from?
Universitas Indonesia (Indonesia)
When is the study starting and how long is it expected to run for?
April 2021 to December 2022
Who is funding the study?
Ministry of Education, Culture, Research and Technology (Indonesia)
Who is the main contact?
Dr Benso Sulijaya, benso.sulijaya87@ui.ac.id, bensosulijaya@gmail.com
Contact information
Public, Scientific, Principal investigator
Jl. Salemba Raya IV No 2
Jakarta Pusat
10430
Indonesia
| Phone | +62 (0)81212286089 |
|---|---|
| bensosulijaya@gmail.com |
Public, Scientific
Jl. Rajawali Selatan 3 no. 11
Jakarta Pusat
10720
Indonesia
| Phone | +62 (0)81808050734 |
|---|---|
| valdy.hartono@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional double-blinded randomized controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Mobile application-based support for periodontal treatment improves clinical, cognitive, and psychomotor outcomes: a randomized controlled trial study |
| Study objectives | Mobile application-based support for periodontal treatment improves clinical, cognitive, and psychomotor aspects more than conventional dental health education |
| Ethics approval(s) |
Approved 21/01/2022, The Dental Research Ethics Committee, Faculty of Dentistry, Universitas Indonesia (Jl. Salemba Raya IV, Jakarta Pusat, 10430, Indonesia; +62 (0)2131906289; etikrisetfkg@ui.ac.id), ref: 01/Ethical Approval /FKGUI/I/2022 |
| Health condition(s) or problem(s) studied | Improving clinical, cognitive, and psychomotor aspects of patients with gingivitis or periodontitis |
| Intervention | Participants were listed and evenly distributed between the test (professional mechanical plaque removal including scaling and root planing and dental health education [PMPR-DHE] + mobile application) and control (PMPR-DHE alone) groups by a masked researcher who was not involved in the clinical examination. A periodontal mobile application intervention was only implemented for participants who belong to the test group. First, the participants were instructed to download and install mobile apps. For every visit, clinical periodontal parameters, which were recorded, were displayed inside the app to ensure that the participants were aware of whether their periodontal condition had improved or deteriorated. Additionally, the app served as a daily dental hygiene reminder for users as well as a constant source of education and motivation for periodontal health maintenance. Instructions on how to perform proper way of brushing and the use of complimentary dental hygiene tools, notably interdental brush and dental floss, were given simultaneously with the daily reminder sent for users through the app, twice a day (every morning and night). Moreover, dental health education were given to users three times a week in the form of interactive posters. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
1. Clinical periodontal parameters: probing pocket depth (PPD) measured using periodontal probe UNC-15 and visual inspection on six tooth surfaces, namely the distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual surfaces of all teeth, except for the third molars, and the average probing depth value was measured at baseline, 1 and 3 months |
| Key secondary outcome measure(s) |
Microbiology periodontal complexes measured using next-generation sequencing (NGS) at baseline, 1 and 3 months |
| Completion date | 01/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 55 Years |
| Sex | Female |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Gingivitis or periodontitis subjects 2. Aged between 35 and 55 years 3. Had never received periodontal therapy only during the previous 6 months 4. Android system-based smartphone users |
| Key exclusion criteria | 1. Systemic conditions related to periodontal disease such as cardiovascular disease, oral cancer, respiratory tract infection, and diabetes 2. Pregnancy or breastfeeding 3. On medication from a health provider 4. Current smokers |
| Date of first enrolment | 21/01/2022 |
| Date of final enrolment | 01/06/2022 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Dental Teaching Hospital
Faculty of Dentistry
Jl. Salemba Raya IV No 2
Jakarta Pusat
10430
Indonesia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to patient confidentiality. However, if only needed, the researchers can provide the patients' informed consent to participate in this study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/04/2024 | 08/03/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/03/2024: Publication reference added.
21/02/2024: Study's existence confirmed by the Dental Research Ethics Committee, Faculty of Dentistry, Universitas Indonesia.
