Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349330
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-03-31
Brief Title:
The Immediate Effectiveness of a 3D Intraoral Scanner as an Oral Hygiene Educational Tool
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
The Immediate Effectiveness of a 3D Intraoral Scanner as an Adjunctive Oral Hygiene Educational Tool A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3D scanner
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 questions 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
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
1 Test n26 3D intra-oral scanning group
2 Control n26 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 experiencesatisfaction in the testcontrol group on the given method of oral hygiene instruction
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
1 Test n26 3D intra-oral scanning group
2 Control n26 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 experiencesatisfaction in the testcontrol group on the given method of oral hygiene instruction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None