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

NCT05073107 | Completed

• 1 other identifier: 2021/00520
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Gingivitis; Plaque, Dental

Keywords

oral hygiene; periodontitis; dental informatics; dental technology; patient reported outcome measures

Outcome Measures

Primary Outcomes (2)

• Full Mouth Plaque Score (%)

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

  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

  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

  At the end of Visit 2 (between Day 28 and 35)

Study Arms (2)

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.

Other: Mobile Dental Application, Dental Monitoring ("DM")

Control: Without Dental Monitoring

NO INTERVENTION

No DM Kit

Interventions

Mobile Dental Application, Dental Monitoring ("DM") OTHER

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.

Test: With Dental Monitoring

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital, Singapore

Singapore, 119074, Singapore

Location

Related Publications (6)

• 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.

  PMID: 32323716 BACKGROUND

• 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.

  PMID: 32020135 BACKGROUND

• 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.

  PMID: 32778857 BACKGROUND

• 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.

  PMID: 32315260 BACKGROUND

• 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.

  PMID: 31573410 BACKGROUND

• 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.

  PMID: 26644730 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Gingivitis; Dental Plaque

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Dental Deposits; Tooth Diseases

Study Officials

• Jia Hui Fu, Dr

  National University Centre for Oral Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: October 11, 2021
• Study Start: December 6, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: February 15, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)