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The Effect of A Dental Application to Promote Self-Administered Plaque Control: A RCT

Primary Purpose

Periodontitis, Gingivitis, Plaque, Dental

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Mobile Dental Application, Dental Monitoring ("DM")
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontitis focused on measuring oral hygiene, periodontitis, dental informatics, dental technology, patient reported outcome measures

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Aged between 21 and 65 years old
  2. Dentate patients
  3. English speaking and literacy for verbal instructions including the usage of the DM application
  4. Have access or own a smartphone with wifi and/or cellular connectivity
  5. Ability to provide informed consent to participate in the study and willing to download the DM application onto their smartphone
  6. Able to link and register their email account to receive notifications from DM application during the study

Exclusion Criteria:

  1. Patients below 21 years old
  2. Patients who is in dental pain
  3. Patients with dementia
  4. Patients who has compromised manual dexterity
  5. Patients who had received Scaling and Polishing less than one month prior to examination and treatment
  6. Pregnant or lactating women

Sites / Locations

  • National University Hospital, Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test: With Dental Monitoring

Control: Without Dental Monitoring

Arm Description

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.

No DM Kit

Outcomes

Primary Outcome Measures

Full Mouth Plaque Score (%)
Difference in Full Mouth Plaque Score using the disclosing two tone liquid by Curaprox
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

Secondary Outcome Measures

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.

Full Information

First Posted
September 2, 2021
Last Updated
February 10, 2022
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05073107
Brief Title
The Effect of A Dental Application to Promote Self-Administered Plaque Control: A RCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
January 14, 2022 (Actual)
Study Completion Date
January 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Gingivitis, Plaque, Dental
Keywords
oral hygiene, periodontitis, dental informatics, dental technology, patient reported outcome measures

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test: With Dental Monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Control: Without Dental Monitoring
Arm Type
No Intervention
Arm Description
No DM Kit
Intervention Type
Other
Intervention Name(s)
Mobile Dental Application, Dental Monitoring ("DM")
Intervention Description
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.
Primary Outcome Measure Information:
Title
Full Mouth Plaque Score (%)
Description
Difference in Full Mouth Plaque Score using the disclosing two tone liquid by Curaprox
Time Frame
Between Visit 1 (Day 0) and Visit 2 (between Day 28 and 35)
Title
Full Mouth Bleeding Score (%)
Description
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
Time Frame
Between Visit 1 (Day 0) and Visit 2 (between Day 28 and 35)
Secondary Outcome Measure Information:
Title
Satisfaction and Ease of Usage of the Dental Monitoring Application/Kit
Description
Participants' experience/feedback in the Test group on the use of the Dental Monitoring application.
Time Frame
At the end of Visit 2 (between Day 28 and 35)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Hui Fu, Dr
Organizational Affiliation
National University Centre for Oral Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital, Singapore
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32323716
Citation
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.
Results Reference
background
PubMed Identifier
32020135
Citation
Chen 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. Erratum In: Quintessence Int. 2020;51(5):430.
Results Reference
background
PubMed Identifier
32778857
Citation
Talla 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.
Results Reference
background
PubMed Identifier
32315260
Citation
Schwendicke 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.
Results Reference
background
PubMed Identifier
31573410
Citation
da 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.
Results Reference
background
PubMed Identifier
26644730
Citation
Avula 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.
Results Reference
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The Effect of A Dental Application to Promote Self-Administered Plaque Control: A RCT

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