Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457321
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-04-04
Brief Title:
Implementation of Digital Workflow for Complete Dentures - A Crossover Study
Sponsor:
National Dental Centre Singapore
Organization:
National Dental Centre Singapore
Study Overview
Official Title:
Implementation of Digital Workflow for Complete Dentures - A Crossover Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
With a demographically ageing population and increasing patients with missing teeth the demands on the healthcare system are set to further increase This project is to prepare the public dental healthcare system to remain sustainable in terms of efficiency of denture production and healthcare manpower lab technicians clinician and operation staff It aims to understand and improve denture fabrication productivity enhance the treatment efficiency This new model of care is a change from the current staged treatment process to batch processing assisted by new manufacturing methods with the goal of improving sustainability and effectiveness of existing clinical and dental lab capacities
Detailed Description:
With an ageing population and growing demand for denture treatments the conventional denture manufacturing method is incapable of meeting the current demand in Singapore due to its labour intensity and low efficiency Such a growing demand urgently necessitates simplification and automation in denture manufacturing Study team propose to deploy and pilot implement a computer-aided design and computer aided manufacturing approach to fabricate the complete dentures With this innovative automated manufacturing approach study team will be able to produce the dentures in a couple of days improve clinical efficiency reduce lab production time and manpower needed The digital workflow will be able to decrease the reliance on technical skills and thus reduce human variation and error and substantially enhance denture fabrication productivity Successful implementation of this innovative denture manufacturing approach will lead to more timely and cost-effective access to denture care for many older Singaporeans thus improving their quality of life
This proposal aims to 1 to evaluate the cost and time used with both digital and conventional workflows 2 to compare clinical outcomes between digital and conventional dentures 3 to evaluate patients satisfaction toward the digital dentures
The long-term goal of this study is to reduce treatment cost and time improve service efficiency and eventually enhance oral function and overall quality of life of complete edentulous patients
Participants will be randomized into 2 groups to determine the sequence of the workflow
Group 1 Conventional then partial digital Group 2 Partial digital than conventional
For conventional method
11 Clinical Examination
Informed consent will be obtained when patients attend the first visit for examination and diagnosis Detailed examination of the oral mucosa and alveolar ridge will be carried out during the initial visit
For conventional workflow primary impressions using alginate impression material will be made with a stock tray for both maxillary and mandibular arches This impression will be poured as a preliminary stone cast for fabrication of a PMMA resin custom impression tray in a conventional dental laboratory
Participant will also be asked to complete questionnaires to rate their current denture
During Fabrication Visit 1-4
3D Denture Patient Questionnaire OHIP EN Pre-issue
3D Denture Patient Questionnaire VAS
12 Master Impression
The customized special tray will be checked in patient mouth for fit and extension followed by border moulding using low fusing impression compound Master impressions will be taken using special trays and zinc oxide impression paste or silicone materials Stone casts will be created using green stone in the dental laboratory The wax base will be constructed on the master models and wax rim will be added
13 Jaw Relation Registration
Adjustment of wax rim will be made by clinicians to determine the vertical jaw relation occlusal plane and lip support The size and shade of the teeth will be selected The models will be mounted in the laboratory and teeth set up will be completed
14 Aesthetic Try-in
The anterior and posterior teeth setup will be verified intraorally in patient Maxillary and mandible relation will be confirmed The articulator will be returned to the lab technician for finishing The final dentures will be fabricated using the polymerizing polymethylmethacrylate resin trimmed and polished by the dental technician
15 Issue of denture
Necessary adjustments may be made by clinicians to meet the retention stability and support requirements The finished complete dentures will be evaluated in the patient mouth Patients will be invited to fill in the questionnaire to report on oral health related quality of life OHRQoL and chewing ability based on the usage of patients existing dentures
16 Follow-up visits
Patients will be followed up two times at 2 weeks and 4 weeks after dentures are issued Necessary modifications to the dentures will be made to ensure the comfort and function of the devices Patients oral health related quality of life and general satisfaction with the complete dentures including aesthetics retention speech chewing and comfort will be assessed using a self-administered questionnaire
For partial digital method
21 Clinic Informed consent will be obtained when the patients attend their first visit for examination and diagnosis upon being called Detailed examination of the oral mucosa and alveolar ridge will be carried out in the initial visit Like the conventional workflow primary impressions with an alginate impression material will be used with a stock tray for both maxillary and mandibular arches This impression will be used to pour a preliminary stone cast
Lab The preliminary stone cast will be thereafter scanned digitally using a lab scanner Design of special tray will be carried out on the computer programme and 3D printing of PMMA resin custom impression tray will be conducted using a resin printer A wax rim can then be conventionally added on top of this resin tray for the next visit
22 Master Impression Maxillomandibular Registration
ClinicThe customized special tray will be checked in patient mouth for fit and extension followed by border moulding using low fusing impression compound Master impressions will be taken using special trays and an addition polymerization silicone material The OVD and maxillomandibular relationship will also be recorded using the wax rims and bite registration material during this visit
Lab The master impression on the intaglio surface and registered wax rim will be scanned using an intra-oral scanner Subsequently the digital set-up of the denture teeth will be done This preliminary teeth set up is then printed in resin for a try in during the next visit
23 Aesthetic Try-in
Clinic The anterior and posterior teeth setup will be verified intraorally in patient Maxillomandibular relationship and aesthetics relation will be verified If changes are required clinicians will be able to trim the resin teeth and base to achieve adequate maxillary and mandible relationship
Lab The eventual verified MMR relationship will be scanned again Adjustments to the digital teeth set up can be adjusted where necessary The final dentures will be printed using the polymerizing polymethylmethacrylate resin trimmed and polished by the dental technician
24 Issue of denture
Necessary adjustments may be made by clinicians to meet the retention stability and support requirements The finished complete dentures will be evaluated in the patient mouth Patients will be invited to fill in the questionnaire to report on oral health related quality of life OHRQoL and chewing ability based on the usage of patients existing dentures
25 Follow-up visits
Patients will be followed up two times at 2 weeks and 4 weeks after dentures are issued Necessary modifications to the dentures will be made to ensure the comfort and function of the devices Patients oral health related quality of life and general satisfaction with the complete dentures including aesthetics retention speech chewing and comfort will be assessed using a self-administered questionnaire
Sequence of issue
The patients will be randomised into 2 groups determining the sequence in which the 2 sets of dentures from both workflows will be issued The initial denture treatment stages from both workflows will be done concurrently However depending on which group they have been randomised into they will be issued the conventional of the partial digital denture first
After reviewing the patient thrice at 2 weeks 4 weeks and 2 months for adjustments where necessary the second set of denture from the other workflow will be issued and reviewed at the same time intervals This allows ample time for the patient to test out and adapt to each set of denture from both workflows
This proposal aims to 1 to evaluate the cost and time used with both digital and conventional workflows 2 to compare clinical outcomes between digital and conventional dentures 3 to evaluate patients satisfaction toward the digital dentures
The long-term goal of this study is to reduce treatment cost and time improve service efficiency and eventually enhance oral function and overall quality of life of complete edentulous patients
Participants will be randomized into 2 groups to determine the sequence of the workflow
Group 1 Conventional then partial digital Group 2 Partial digital than conventional
For conventional method
11 Clinical Examination
Informed consent will be obtained when patients attend the first visit for examination and diagnosis Detailed examination of the oral mucosa and alveolar ridge will be carried out during the initial visit
For conventional workflow primary impressions using alginate impression material will be made with a stock tray for both maxillary and mandibular arches This impression will be poured as a preliminary stone cast for fabrication of a PMMA resin custom impression tray in a conventional dental laboratory
Participant will also be asked to complete questionnaires to rate their current denture
During Fabrication Visit 1-4
3D Denture Patient Questionnaire OHIP EN Pre-issue
3D Denture Patient Questionnaire VAS
12 Master Impression
The customized special tray will be checked in patient mouth for fit and extension followed by border moulding using low fusing impression compound Master impressions will be taken using special trays and zinc oxide impression paste or silicone materials Stone casts will be created using green stone in the dental laboratory The wax base will be constructed on the master models and wax rim will be added
13 Jaw Relation Registration
Adjustment of wax rim will be made by clinicians to determine the vertical jaw relation occlusal plane and lip support The size and shade of the teeth will be selected The models will be mounted in the laboratory and teeth set up will be completed
14 Aesthetic Try-in
The anterior and posterior teeth setup will be verified intraorally in patient Maxillary and mandible relation will be confirmed The articulator will be returned to the lab technician for finishing The final dentures will be fabricated using the polymerizing polymethylmethacrylate resin trimmed and polished by the dental technician
15 Issue of denture
Necessary adjustments may be made by clinicians to meet the retention stability and support requirements The finished complete dentures will be evaluated in the patient mouth Patients will be invited to fill in the questionnaire to report on oral health related quality of life OHRQoL and chewing ability based on the usage of patients existing dentures
16 Follow-up visits
Patients will be followed up two times at 2 weeks and 4 weeks after dentures are issued Necessary modifications to the dentures will be made to ensure the comfort and function of the devices Patients oral health related quality of life and general satisfaction with the complete dentures including aesthetics retention speech chewing and comfort will be assessed using a self-administered questionnaire
For partial digital method
21 Clinic Informed consent will be obtained when the patients attend their first visit for examination and diagnosis upon being called Detailed examination of the oral mucosa and alveolar ridge will be carried out in the initial visit Like the conventional workflow primary impressions with an alginate impression material will be used with a stock tray for both maxillary and mandibular arches This impression will be used to pour a preliminary stone cast
Lab The preliminary stone cast will be thereafter scanned digitally using a lab scanner Design of special tray will be carried out on the computer programme and 3D printing of PMMA resin custom impression tray will be conducted using a resin printer A wax rim can then be conventionally added on top of this resin tray for the next visit
22 Master Impression Maxillomandibular Registration
ClinicThe customized special tray will be checked in patient mouth for fit and extension followed by border moulding using low fusing impression compound Master impressions will be taken using special trays and an addition polymerization silicone material The OVD and maxillomandibular relationship will also be recorded using the wax rims and bite registration material during this visit
Lab The master impression on the intaglio surface and registered wax rim will be scanned using an intra-oral scanner Subsequently the digital set-up of the denture teeth will be done This preliminary teeth set up is then printed in resin for a try in during the next visit
23 Aesthetic Try-in
Clinic The anterior and posterior teeth setup will be verified intraorally in patient Maxillomandibular relationship and aesthetics relation will be verified If changes are required clinicians will be able to trim the resin teeth and base to achieve adequate maxillary and mandible relationship
Lab The eventual verified MMR relationship will be scanned again Adjustments to the digital teeth set up can be adjusted where necessary The final dentures will be printed using the polymerizing polymethylmethacrylate resin trimmed and polished by the dental technician
24 Issue of denture
Necessary adjustments may be made by clinicians to meet the retention stability and support requirements The finished complete dentures will be evaluated in the patient mouth Patients will be invited to fill in the questionnaire to report on oral health related quality of life OHRQoL and chewing ability based on the usage of patients existing dentures
25 Follow-up visits
Patients will be followed up two times at 2 weeks and 4 weeks after dentures are issued Necessary modifications to the dentures will be made to ensure the comfort and function of the devices Patients oral health related quality of life and general satisfaction with the complete dentures including aesthetics retention speech chewing and comfort will be assessed using a self-administered questionnaire
Sequence of issue
The patients will be randomised into 2 groups determining the sequence in which the 2 sets of dentures from both workflows will be issued The initial denture treatment stages from both workflows will be done concurrently However depending on which group they have been randomised into they will be issued the conventional of the partial digital denture first
After reviewing the patient thrice at 2 weeks 4 weeks and 2 months for adjustments where necessary the second set of denture from the other workflow will be issued and reviewed at the same time intervals This allows ample time for the patient to test out and adapt to each set of denture from both workflows
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