The Immediate Effectiveness of a 3D Intraoral Scanner as an Oral Hygiene Educational Tool

NCT06349330 | Completed

• 1 other identifier: 2022/00908
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled clinical trial is to compare the immediate effectiveness of 3D intra-oral scanners and standard oral hygiene instructions in improving the oral hygiene of 52 subjects. The main question\[s\] it aims to answer are:

• Does a 3D intra-oral scanner facilitate the improvement of oral hygiene in subjects?
• Does a 3D-rendered image of plaque-stained teeth confer better visualization to subjects? Prospective Open Cohort study: Patients referred to NUCOHS Periodontology Department will be invited to participate in the study. Included participants will be randomized into the 3D scanner (test) and standard oral hygiene (control) group. Subsequently, both groups will receive personalized oral hygiene instructions before brushing their teeth. The participants will receive plaque disclosing again to compare the differences between baseline and post-intervention. Routine periodontal parameters will be recorded at baseline and researchers will compare the percentage improvement in full mouth plaque scores to see if the test group performed better than the control group. A questionnaire will be given to subjects in the test and control group for qualitative analysis. The study will require 1 visit.

Conditions

Periodontal Diseases; Plaque Induced Gingival Disease

Keywords

Oral hygiene instruction; Oral hygiene education

Outcome Measures

Primary Outcomes (1)

• Full mouth plaque score (%)

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

  Immediate/1 day

Secondary Outcomes (1)

• Patient's satisfaction of 3D scanner and standard oral hygiene group based on 5-point Likert Scale

  Immediate/1 day

Study Arms (2)

3D intra-oral scanner

EXPERIMENTAL

Subjects will undergo 3D scanning and the 3D rendered image will be used to facilitate oral hygiene instructions.

Device: Test: 3D intra-oral scanner

Standard oral hygiene

ACTIVE COMPARATOR

Subjects will receive standard oral hygiene instructions with hand mirror.

Other: Control: Standard oral hygiene

Interventions

Test: 3D intra-oral scanner DEVICE

3D intra-oral scanner will be used to scan the subjects after plaque staining is performed. Subsequently, a 3D rendered image will be produced. Participants will be given oral hygiene education and instruction before being instructed to brush. A cooling-off period of 30 minutes is given before participants are instructed to brush.

3D intra-oral scanner

Control: Standard oral hygiene OTHER

Standard oral hygiene instructions will be delivered using a hand mirror. No 3D intraoral scanner will be used.

Standard oral hygiene

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy patients (ASA I and ASA II)
• ≥ 20 teeth, excluding impacted third molars
• , between ages 21 and 75 years
• plaque score (PS) ≥ 50%
• Bleeding on probing ≥ 30% of sites
• At least 1 molar is present on each sextant
• Probing pocket depths (PPD) should be ≤ 6 mm (h) Willingness to give consent

You may not qualify if:

• Presence of PPD ≥ 7 mm, excluding the distal of 7s due to impacted wisdom teeth
• Presence of fixed retainers
• Presence of fixed orthodontic appliances
• Pregnant and lactating patients
• Cognitive impairments
• Initiation of antibiotic therapy or antiseptic mouth rinse within 2 weeks before the study
• Patients with known neuromotor deficits e.g. Parkinsonism, Dementia, Alzheimer's Disease
• Diseases or medications, medications that may affect treatment
• Heavy smokers ≥ 10 sticks/day,
• Unwillingness to undergo periodontal treatment
• Uncontrolled diabetes mellitus and hypertension
• Teeth with crowns and bridges
• Unwillingness to undergo the proposed protocol

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital, Singapore

Singapore, Singapore

Location

Related Publications (2)

• Doi K, Yoshiga C, Kobatake R, Kawagoe M, Wakamatsu K, Tsuga K. Use of an intraoral scanner to evaluate oral health. J Oral Sci. 2021 Jun 29;63(3):292-294. doi: 10.2334/josnusd.21-0048. Epub 2021 Jun 9.

  PMID: 34108300 BACKGROUND

• Jung K, Giese-Kraft K, Fischer M, Schulze K, Schlueter N, Ganss C. Visualization of dental plaque with a 3D-intraoral-scanner-A tool for whole mouth planimetry. PLoS One. 2022 Oct 26;17(10):e0276686. doi: 10.1371/journal.pone.0276686. eCollection 2022.

  PMID: 36288348 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Xiao Tong Lu Jacinta 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: This is a parallel-arm randomized controlled trial and subjects are randomized into test and control groups via block randomization. To investigate the immediate effectiveness on the use of 3D intraoral scanner in the improvement of oral hygiene in two (2) parallel arm study with 52 subjects (n=52). The study will take place over 1 visit.

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: November 7, 2023
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)