PeriodontitisNCT05073107
The Effect of A Dental Application to Promote Self-Administered Plaque Control: A RCT
A study testing Mobile Dental Application, Dental Monitoring ("DM") in people with Periodontitis and Gingivitis, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Randomized Controlled Trial: to investigate the feasibility of the usage of a mobile dental application in the self-administration of plaque control in a two (2) parallel arm study with 52 subjects (n = 52). The study will take place over 2 visits (within 35 days): Visit 1 and 2. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis, Plaque, Dental
- What is being tested?
- Mobile Dental Application, Dental Monitoring ("DM")
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Dec 2021to 14 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 21 and 65 years old
- Dentate patients
- English speaking and literacy for verbal instructions including the usage of the DM application
- Have access or own a smartphone with wifi and/or cellular connectivity
- Ability to provide informed consent to participate in the study and willing to download the DM application onto their smartphone
- Able to link and register their email account to receive notifications from DM application during the study
Who cannot join
- Patients below 21 years old
- Patients who is in dental pain
- Patients with dementia
- Patients who has compromised manual dexterity
- Patients who had received Scaling and Polishing less than one month prior to examination and treatment
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of An Artificial Intelligence ("AI") Mobile Dental Application ("Dental Monitoring") in the Promotion of Self-Administered Plaque Control: A Randomized Controlled Trial
Randomized Controlled Trial: to investigate the feasibility of the usage of a mobile dental application in the self-administration of plaque control in a two (2) parallel arm study with 52 subjects (n = 52). The study will take place over 2 visits (within 35 days): Visit 1 and 2.
Prospective Open Cohort Study: Patients referred to the Periodontology Department will be invited to participate in the study during the Oral Hygiene Phase. Routine clinical indices will be recorded at Visit 1 and Visit 2 before active non-surgical periodontal treatment commences.
Read the detailed description
Visit 1 (Week 0, Day 0): Start of Study
- Subjects: The periodontal patients who have a dental appointment scheduled in the National University Centre for Oral Health, Singapore and fulfil inclusion/exclusion criteria will be recruited into the study by the delegated study team members. After written informed consent has been obtained and all the standard dental practices such as collecting the Routine Clinical Periodontal Parameters for evaluation and providing Oral Hygiene Instruction are done by the blinded study team member(s) termed as the Examiner. After which, the Participants will be randomized into 2 groups by delegated study team members.
- There will be two groups:
- Test (n = 26): Dental Monitoring ("DM") Kit + 2-month DM subscription
- Control (n = 26): No DM Kit
- The Examiner will be either the Co-investigator or an oral hygiene therapist engaged to be on the delegated study team. The same single blinded Examiner will examine all the participants of the study at both Visits 1 and 2.
- Based on the design of the study, there will be no deviation from the standard periodontal treatment protocol and intervals between treatment for this group of patients in the public healthcare setting with the exception for the test groups whereby the usage of an additional DM application which will be evaluated in this study.
- The Test group will receive DM as an additional monitoring aid. The delegated study team members will guide the Test group to download the DM application onto their mobile device, provide them with a DM Kit including full instructions (verbal and instruction pamphlet).
- In addition, the Test group will be taught by the delegated study team members:
- How to pair up a DM Scanbox with your smartphone https://youtu.be/y-q9Z8JMbzo
- How to perform DM Scans with ScanBox https://youtu.be/YT859VMGL18
- The Test group will be required to take intra-oral videos (which will be translated into photographs) using the DM application weekly and it will be monitored by the delegated team members:
- Day 0 (To be taken at the clinic)
- Day 7 (To be taken in the evening after brushing teeth)
- Day 14 (To be taken in the evening after brushing teeth)
- Day 21(To be taken in the evening after brushing teeth)
- Day 28 (To be taken before study Visit 2) *There is a window period of +1 day for the intra-oral videos.
- The Control group will monitor their own oral hygiene without any additional aids.
- All patients will be given a soft-bristled toothbrush, fluoridated toothpaste and inter-dental aids by the delegated study team members. They will be instructed not to use any forms of mouth rinse.
Visit 2 (Week 4, Day 28 to Day 35): End of Study
- This visit will be between Day 28 and 35.
- The Test group will be given a short questionnaire by delegated study team members to evaluate their perspective on the "ease of use" and "satisfaction" using DM.
- The same Routine Clinical Periodontal Parameters clinical parameters will be measured again by the same blinded Examiner in Visit 1 and the clinical parameters evaluated.
- At the end of Visit 2, the subject will need to return the DM Kit during this visit. There is no more post follow up for this study and patient will continue with their next scheduled dental appointment by their primary care team.
- The delegated study team will collect the data from the Routine Clinical Periodontal Parameters (Full Mouth Periodontal Probing Depth, Bleeding on Probing, Recession and Plaque Index) that have been recorded at Visit 1 and Visit 2 for the following:
- Primary Outcome: Difference in Full Mouth Plaque Score (%)
- Secondary Outcomes: Participants' experience/feedback in the Test group on the use of the Dental Monitoring application.
- The delegated study team will analyze the photographs taken by the DM application and the data collected via the questionnaire.
- Conditions
- Periodontitis, Gingivitis, Plaque, Dental
- Being tested
- Mobile Dental Application, Dental Monitoring ("DM")
- Keywords
- oral hygiene, periodontitis, dental informatics, dental technology, patient reported outcome measures
- Medical subject headings
- Periodontitis, Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Dental Application, Dental Monitoring ("DM")Other
- The Test group will be required to take intra-oral videos (which will be translated into photographs) using the DM application weekly and it will be monitored by the delegated team members:
- Day 0 (To be taken at the clinic)
- Day 7 (To be taken in the evening after brushing teeth)
- Day 14 (To be taken in the evening after brushing teeth)
- Day 21(To be taken in the evening after brushing teeth)
- Day 28 (To be taken before study Visit 2) There is a window period of +1 day for the intra-oral videos.
| Study group | Role | What they receive |
|---|---|---|
| Test: With Dental Monitoring | Experimental | Dental Monitoring ("DM") Kit + 2-month DM subscription
Required to take intra-oral videos (which will be translated into photographs) using the DM application weekly and it will be monitored by the delegated team members:
* Day 0 (To be taken at the clinic)
* Day 7 (To be taken in the evening after brushing teeth)
* Day 14 (To be taken in the evening after brushing teeth)
* Day 21(To be taken in the evening after brushing teeth)
* Day 28 (To be taken before study Visit 2)
There is a window period of +1 day for the intra-oral videos. Receives: Other: Mobile Dental Application, Dental Monitoring ("DM") |
| Control: Without Dental Monitoring | No intervention | No DM Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full Mouth Plaque Score (%)
Difference in Full Mouth Plaque Score using the disclosing two tone liquid by Curaprox
Measured: Between Visit 1 (Day 0) and Visit 2 (between Day 28 and 35)
Full Mouth Bleeding Score (%)
Difference in Full Mouth Bleeding Score using a UNC periodontal probe, 6 surfaces per tooth (mesio-buccal, mid buccal, disco-buccal, mesio-lingual, mid-lingual and ditto-lingual) will be measured
Measured: Between Visit 1 (Day 0) and Visit 2 (between Day 28 and 35)
Secondary outcomes (1)
Satisfaction and Ease of Usage of the Dental Monitoring Application/Kit
Participants' experience/feedback in the Test group on the use of the Dental Monitoring application.
Measured: At the end of Visit 2 (between Day 28 and 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start6 Dec 2021
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To investigate the feasibility of the usage of a mobile dental application in the self-administration of plaque control in a two (2) parallel arm study with 52 subjects (n = 52). The study will take place over 2 visits (within 35 days): Visit 1 and 2.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia Hui Fu, Dr, Principal investigator, National University Centre for Oral Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073107
- Sponsor's protocol ID
- 2021/00520
- Status last verified
- Apr 2021
- First submitted
- 2 Sep 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Impellizzeri A, Horodinsky M, Barbato E, Polimeni A, Salah P, Galluccio G. Dental Monitoring Application: it is a valid innovation in the Orthodontics Practice? Clin Ter. 2020 May-Jun;171(3):e260-e267. doi: 10.7417/CT.2020.2224.
PubMed 32323716Chen YW, Stanley K, Att W. Artificial intelligence in dentistry: current applications and future perspectives. Quintessence Int. 2020;51(3):248-257. doi: 10.3290/j.qi.a43952.
PubMed 32020135Talla PK, Levin L, Glogauer M, Cable C, Allison PJ. Delivering dental care as we emerge from the initial phase of the COVID-19 pandemic: teledentistry and face-to-face consultations in a new clinical world. Quintessence Int. 2020;51(8):672-677. doi: 10.3290/j.qi.a44920.
PubMed 32778857Schwendicke F, Samek W, Krois J. Artificial Intelligence in Dentistry: Chances and Challenges. J Dent Res. 2020 Jul;99(7):769-774. doi: 10.1177/0022034520915714. Epub 2020 Apr 21.
PubMed 32315260da Costa CB, Peralta FDS, Ferreira de Mello ALS. How Has Teledentistry Been Applied in Public Dental Health Services? An Integrative Review. Telemed J E Health. 2020 Jul;26(7):945-954. doi: 10.1089/tmj.2019.0122. Epub 2019 Oct 1.
PubMed 31573410Avula H. Tele-periodontics - Oral health care at a grass root level. J Indian Soc Periodontol. 2015 Sep-Oct;19(5):589-92. doi: 10.4103/0972-124X.157875.
PubMed 26644730
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of An Artificial Intelligence ("AI") Mobile Dental Application ("Dental Monitoring") in the Promotion of Self-Administered Plaque Control: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05073107
- Acronym / sponsor ID
- 2021/00520
- Conditions
- Periodontitis, Gingivitis, Plaque, Dental
- Keywords
- oral hygiene, periodontitis, dental informatics, dental technology, patient reported outcome measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized Controlled Trial: to investigate the feasibility of the usage of a mobile dental application in the self-administration of plaque control in a two (2) parallel arm study with 52 subjects (n = 52). The study will take place over 2 visits (within 35 days): Visit 1 and 2.
Prospective Open Cohort Study: Patients referred to the Periodontology Department will be invited to participate in the study during the Oral Hygiene Phase. Routine clinical indices will be recorded at Visit 1 and Visit 2 before active non-surgical periodontal treatment commences.
Detailed description
Visit 1 (Week 0, Day 0): Start of Study
- Subjects: The periodontal patients who have a dental appointment scheduled in the National University Centre for Oral Health, Singapore and fulfil inclusion/exclusion criteria will be recruited into the study by the delegated study team members. After written informed consent has been obtained and all the standard dental practices such as collecting the Routine Clinical Periodontal Parameters for evaluation and providing Oral Hygiene Instruction are done by the blinded study team member(s) termed as the Examiner. After which, the Participants will be randomized into 2 groups by delegated study team members.
- There will be two groups:
- Test (n = 26): Dental Monitoring ("DM") Kit + 2-month DM subscription
- Control (n = 26): No DM Kit
- The Examiner will be either the Co-investigator or an oral hygiene therapist engaged to be on the delegated study team. The same single blinded Examiner will examine all the participants of the study at both Visits 1 and 2.
- Based on the design of the study, there will be no deviation from the standard periodontal treatment protocol and intervals between treatment for this group of patients in the public healthcare setting with the exception for the test groups whereby the usage of an additional DM application which will be evaluated in this study.
- The Test group will receive DM as an additional monitoring aid. The delegated study team members will guide the Test group to download the DM application onto their mobile device, provide them with a DM Kit including full instructions (verbal and instruction pamphlet).
- In addition, the Test group will be taught by the delegated study team members:
- How to pair up a DM Scanbox with your smartphone https://youtu.be/y-q9Z8JMbzo
- How to perform DM Scans with ScanBox https://youtu.be/YT859VMGL18
- The Test group will be required to take intra-oral videos (which will be translated into photographs) using the DM application weekly and it will be monitored by the delegated team members:
- Day 0 (To be taken at the clinic)
- Day 7 (To be taken in the evening after brushing teeth)
- Day 14 (To be taken in the evening after brushing teeth)
- Day 21(To be taken in the evening after brushing teeth)
- Day 28 (To be taken before study Visit 2) *There is a window period of +1 day for the intra-oral videos.
- The Control group will monitor their own oral hygiene without any additional aids.
- All patients will be given a soft-bristled toothbrush, fluoridated toothpaste and inter-dental aids by the delegated study team members. They will be instructed not to use any forms of mouth rinse.
Visit 2 (Week 4, Day 28 to Day 35): End of Study
- This visit will be between Day 28 and 35.
- The Test group will be given a short questionnaire by delegated study team members to evaluate their perspective on the "ease of use" and "satisfaction" using DM.
- The same Routine Clinical Periodontal Parameters clinical parameters will be measured again by the same blinded Examiner in Visit 1 and the clinical parameters evaluated.
- At the end of Visit 2, the subject will need to return the DM Kit during this visit. There is no more post follow up for this study and patient will continue with their next scheduled dental appointment by their primary care team.
- The delegated study team will collect the data from the Routine Clinical Periodontal Parameters (Full Mouth Periodontal Probing Depth, Bleeding on Probing, Recession and Plaque Index) that have been recorded at Visit 1 and Visit 2 for the following:
- Primary Outcome: Difference in Full Mouth Plaque Score (%)
- Secondary Outcomes: Participants' experience/feedback in the Test group on the use of the Dental Monitoring application.
- The delegated study team will analyze the photographs taken by the DM application and the data collected via the questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- To investigate the feasibility of the usage of a mobile dental application in the self-administration of plaque control in a two (2) parallel arm study with 52 subjects (n = 52). The study will take place over 2 visits (within 35 days): Visit 1 and 2.
| Arm | Type | Receives |
|---|---|---|
| Test: With Dental Monitoring | Experimental | Other: Mobile Dental Application, Dental Monitoring ("DM")Dental Monitoring ("DM") Kit + 2-month DM subscription Required to take intra-oral videos (which will be translated into photographs) using the DM application weekly and it will be monitored by the delegated team members: * Day 0 (To be taken at the clinic) * Day 7 (To be taken in the evening after brushing teeth) * Day 14 (To be taken in the evening after brushing teeth) * Day 21(To be taken in the evening after brushing teeth) * Day 28 (To be taken before study Visit 2) There is a window period of +1 day for the intra-oral videos. |
| Control: Without Dental Monitoring | No intervention | –No DM Kit |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 21 and 65 years old
- Dentate patients
- English speaking and literacy for verbal instructions including the usage of the DM application
- Have access or own a smartphone with wifi and/or cellular connectivity
- Ability to provide informed consent to participate in the study and willing to download the DM application onto their smartphone
Key exclusion criteria (6 listed)
- Patients below 21 years old
- Patients who is in dental pain
- Patients with dementia
- Patients who has compromised manual dexterity
- Patients who had received Scaling and Polishing less than one month prior to examination and treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Dental Application, Dental Monitoring ("DM")o The Test group will be required to take intra-oral videos (which will be translated into photographs) using the DM application weekly and it will be monitored by the delegated team members: * Day 0 (To be taken at the clinic) * Day 7 (To be taken in the evening after brushing teeth) * Day 14 (To be taken in the evening after brushing teeth) * Day 21(To be taken in the evening after brushing teeth) * Day 28 (To be taken before study Visit 2) There is a window period of +1 day for the intra-oral videos. | Other | Test: With Dental Monitoring |
Primary outcome
Full Mouth Plaque Score (%)
Time frame: Between Visit 1 (Day 0) and Visit 2 (between Day 28 and 35)
Difference in Full Mouth Plaque Score using the disclosing two tone liquid by Curaprox
Full Mouth Bleeding Score (%)
Time frame: Between Visit 1 (Day 0) and Visit 2 (between Day 28 and 35)
Difference in Full Mouth Bleeding Score using a UNC periodontal probe, 6 surfaces per tooth (mesio-buccal, mid buccal, disco-buccal, mesio-lingual, mid-lingual and ditto-lingual) will be measured
1 secondary outcome
Satisfaction and Ease of Usage of the Dental Monitoring Application/Kit
Time frame: At the end of Visit 2 (between Day 28 and 35)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Background: PubMed 32323716Impellizzeri A, Horodinsky M, Barbato E, Polimeni A, Salah P, Galluccio G. Dental Monitoring Application: it is a valid innovation in the Orthodontics Practice? Clin Ter. 2020 May-Jun;171(3):e260-e267. doi: 10.7417/CT.2020.2224.
- Background: PubMed 32020135Chen YW, Stanley K, Att W. Artificial intelligence in dentistry: current applications and future perspectives. Quintessence Int. 2020;51(3):248-257. doi: 10.3290/j.qi.a43952.
- Background: PubMed 32778857Talla PK, Levin L, Glogauer M, Cable C, Allison PJ. Delivering dental care as we emerge from the initial phase of the COVID-19 pandemic: teledentistry and face-to-face consultations in a new clinical world. Quintessence Int. 2020;51(8):672-677. doi: 10.3290/j.qi.a44920.
- Background: PubMed 32315260Schwendicke F, Samek W, Krois J. Artificial Intelligence in Dentistry: Chances and Challenges. J Dent Res. 2020 Jul;99(7):769-774. doi: 10.1177/0022034520915714. Epub 2020 Apr 21.
- Background: PubMed 31573410da Costa CB, Peralta FDS, Ferreira de Mello ALS. How Has Teledentistry Been Applied in Public Dental Health Services? An Integrative Review. Telemed J E Health. 2020 Jul;26(7):945-954. doi: 10.1089/tmj.2019.0122. Epub 2019 Oct 1.
- Background: PubMed 26644730Avula H. Tele-periodontics - Oral health care at a grass root level. J Indian Soc Periodontol. 2015 Sep-Oct;19(5):589-92. doi: 10.4103/0972-124X.157875.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Hui Fu, Dr principal investigator
National University Centre for Oral Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Dental Application, Dental Monitoring ("DM") in people with Periodontitis and Gingivitis, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full Mouth Plaque Score (%) (time frame: Between Visit 1 (Day 0) and Visit 2 (between Day 28 and 35)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05073107, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.