Periodontal Diseases3D scannerNCT06349330
The Immediate Effectiveness of a 3D Intraoral Scanner as an Oral Hygiene Educational Tool
A study testing Test: 3D intra-oral scanner in people with Periodontal Diseases and Plaque Induced Gingival Disease, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Plaque Induced Gingival Disease
- What is being tested?
- Test: 3D intra-oral scanner
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Nov 2023to 3 Jun 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Immediate Effectiveness of a 3D Intraoral Scanner as an Adjunctive Oral Hygiene Educational Tool: A Randomized Controlled Trial
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?
Read more
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.
Read the detailed description
Subjects:
The randomized controlled study will include 52 healthy volunteers from the National University Centre of Oral Health (NUCOHS), Department of Periodontology. The sample size is calculated with the assumption of a large Cohen effect size. The subjects are patients undergoing periodontal therapy in the center. After written informed consent has been obtained, the baseline periodontal parameters will be obtained to assess for inclusion and exclusion criteria. Successfully included participants will be randomized into 2 groups by blinded study team members.
There will be 2 groups:
- Test (n=26): 3D intra-oral scanning group.
- Control (n=26): standard oral hygiene instructions (no 3D intra-oral scanning).
Examiner:
- The blinded examiner will perform the baseline examination and the post-intervention examination.
- An unblinded examiner will perform either a) intra-oral scanning and give tailored OHI and OHE using the 3D rendered image or b) give OHI and OHE using conventional models. A standardized protocol for OHI and OHE is given to calibrate the overall instructions given.
- The standardized protocol will include a demonstration of the modified bass technique using a tooth model as well as intra-orally. Interdental brushes (Curaprox) will be fitted according to the size of the interdental gap using the Curaprox Interproximal Access Probe (IAP PROBE). Its use will be demonstrated intra-orally using a hand mirror in both groups.
- Based on the design of the study, there will be no deviation from standard periodontal treatment protocol with the exception that the test group will receive 3D intraoral scanning during oral hygiene education and instructions.
- At the end of the visit, participants from both test and control group will be given a short questionnaire by delegated study team members to evaluate their perspectives on 3D scanning (test) and standard oral hygiene (control).
Results collection:
- The delegated study member will collect the data collected during the clinical periodontal examination that has been recorded during the visit.
Primary outcome: Difference in the full mouth plaque score (%). Secondary outcomes: Participants experience/satisfaction in the test/control group on the given method of oral hygiene instruction.
- Being tested
- Test: 3D intra-oral scanner, Control: Standard oral hygiene
- Keywords
- Oral hygiene instruction, Oral hygiene education
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test: 3D intra-oral scannerDevice
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.
Control: Standard oral hygieneOther
Standard oral hygiene instructions will be delivered using a hand mirror. No 3D intraoral scanner will be used.
| Study group | Role | What they receive |
|---|---|---|
| 3D intra-oral scanner | Experimental | Subjects will undergo 3D scanning and the 3D rendered image will be used to facilitate oral hygiene instructions. Receives: Device: Test: 3D intra-oral scanner |
| Standard oral hygiene | Active comparator | Subjects will receive standard oral hygiene instructions with hand mirror. Receives: Other: Control: Standard oral hygiene |
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 two tone plaque disclosing liquid by Curaprox
Measured: Immediate/1 day
Secondary outcomes (1)
Patient's satisfaction of 3D scanner and standard oral hygiene group based on 5-point Likert Scale
Patient's acceptability to the control and intervention will be measured by a 5-point Likert scale questionnaire.
Measured: Immediate/1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start7 Nov 2023
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- 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.
- 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
- Xiao Tong Lu Jacinta Dr, Principal investigator, National University Centre for Oral Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349330
- Sponsor's protocol ID
- 2022/00908
- Acronym
- 3D scanner
- Status last verified
- Jul 2024
- First submitted
- 31 Mar 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34108300Jung 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.
PubMed 36288348Choo HJS, Xie JMJ, Lu XTJ, Lai WMC, Lim LP, Yeo BKA. The Immediate Effects of a 3D Intraoral Scanner as an Adjunctive Oral Hygiene Educational Tool: A Randomised Controlled Trial. Int J Dent Hyg. 2026 May 17. doi: 10.1111/idh.70091. Online ahead of print.
PubMed 42143740
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effectiveness of a 3D Intraoral Scanner as an Adjunctive Oral Hygiene Educational Tool: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06349330
- Acronym / sponsor ID
- 3D scanner / 2022/00908
- Keywords
- Oral hygiene instruction, Oral hygiene education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 5 Apr 2024 (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.
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.
Detailed description
Subjects:
The randomized controlled study will include 52 healthy volunteers from the National University Centre of Oral Health (NUCOHS), Department of Periodontology. The sample size is calculated with the assumption of a large Cohen effect size. The subjects are patients undergoing periodontal therapy in the center. After written informed consent has been obtained, the baseline periodontal parameters will be obtained to assess for inclusion and exclusion criteria. Successfully included participants will be randomized into 2 groups by blinded study team members.
There will be 2 groups:
- Test (n=26): 3D intra-oral scanning group.
- Control (n=26): standard oral hygiene instructions (no 3D intra-oral scanning).
Examiner:
- The blinded examiner will perform the baseline examination and the post-intervention examination.
- An unblinded examiner will perform either a) intra-oral scanning and give tailored OHI and OHE using the 3D rendered image or b) give OHI and OHE using conventional models. A standardized protocol for OHI and OHE is given to calibrate the overall instructions given.
- The standardized protocol will include a demonstration of the modified bass technique using a tooth model as well as intra-orally. Interdental brushes (Curaprox) will be fitted according to the size of the interdental gap using the Curaprox Interproximal Access Probe (IAP PROBE). Its use will be demonstrated intra-orally using a hand mirror in both groups.
- Based on the design of the study, there will be no deviation from standard periodontal treatment protocol with the exception that the test group will receive 3D intraoral scanning during oral hygiene education and instructions.
- At the end of the visit, participants from both test and control group will be given a short questionnaire by delegated study team members to evaluate their perspectives on 3D scanning (test) and standard oral hygiene (control).
Results collection:
- The delegated study member will collect the data collected during the clinical periodontal examination that has been recorded during the visit.
Primary outcome: Difference in the full mouth plaque score (%). Secondary outcomes: Participants experience/satisfaction in the test/control group on the given method of oral hygiene instruction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 3D intra-oral scanner | Experimental | Device: Test: 3D intra-oral scannerSubjects will undergo 3D scanning and the 3D rendered image will be used to facilitate oral hygiene instructions. |
| Standard oral hygiene | Active comparator | Other: Control: Standard oral hygieneSubjects will receive standard oral hygiene instructions with hand mirror. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Test: 3D intra-oral scanner3D 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. | Device | 3D intra-oral scanner |
| Control: Standard oral hygieneStandard oral hygiene instructions will be delivered using a hand mirror. No 3D intraoral scanner will be used. | Other | Standard oral hygiene |
Primary outcome
Full mouth plaque score (%)
Time frame: Immediate/1 day
Difference in Full Mouth Plaque Score using the two tone plaque disclosing liquid by Curaprox
1 secondary outcome
Patient's satisfaction of 3D scanner and standard oral hygiene group based on 5-point Likert Scale
Time frame: Immediate/1 day
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 17 Jul 2024.
- Background: PubMed 34108300Doi 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.
- Background: PubMed 36288348Jung 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.
- Derived from this study: PubMed 42143740Choo HJS, Xie JMJ, Lu XTJ, Lai WMC, Lim LP, Yeo BKA. The Immediate Effects of a 3D Intraoral Scanner as an Adjunctive Oral Hygiene Educational Tool: A Randomised Controlled Trial. Int J Dent Hyg. 2026 May 17. doi: 10.1111/idh.70091. Online ahead of print.
- 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.
Xiao Tong Lu Jacinta 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 Test: 3D intra-oral scanner in people with Periodontal Diseases and Plaque Induced Gingival Disease, 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 7 inclusion and 13 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 17 Jul 2024. 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: Immediate/1 day). 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 NCT06349330, which also lists 3 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 17 Jul 2024.