The Effect of A Dental Application to Promote Self-Administered Plaque Control: A RCT
Condition: Periodontitis; Gingivitis; Plaque, Dental
MeSH terms: Gingivitis; Periodontitis; Dental Plaque
Study type: Interventional

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:

             1. How to pair up a DM Scanbox with your smartphone https://youtu.be/y-q9Z8JMbzo

             2. 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.
    

Intervention name(s): Mobile Dental Application, Dental Monitoring ("DM")
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Investigator)
Primary purpose: Prevention
Keywords: oral hygiene; periodontitis; dental informatics; dental technology; patient reported outcome measures