Implementation of Digital Workflow for Complete Dentures - A Crossover Study
NCT Number: NCT06457321
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Complete Edentulism
Interventions: PROCEDURE: Sequence in receiving the fabricated dentures made using the conventional and partial digital method
Sponsor: National Dental Centre, Singapore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2026-12-31

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.

Primary Outcome Measures: Patients' Oral Health Quality of Life, To investigate patients' perceived oral health related quality of life (OHRQoL) by comparing patients' responses after receiving complete dentures fabricated by conventional or digital workflows.

This will be completed at 5 time points:

1. before receiving Denture 1
2. 4 weeks after using Denture 1
3. 2 months after using Denture 1
4. 4 weeks after using Denture 2
5. 2 months after using Denture 2

Denture 1 and 2 can be either conventionally made denture or denture made from partial digital method.

There are a total of 14 questions and each question has 5 options to choose from and scores are tagged to the options ranging from 0 to 4. The total minimum and maximum score for each attempt is 0 and 56 respectively. The higher the score, the worser the QoL., End of 2 months review of Denture 1 and Denture 2 respectively|Patients' Denture Satisfaction, To investigate patients' satisfaction towards the denture fabricated using the McGill Denture satisfaction questionnaire by comparing patients' responses after receiving complete dentures fabricated by conventional or digital workflows.

The set of questionnaires will have to be completed at 5 time points:

1. before receiving Denture 1
2. 4 weeks after using Denture 1
3. 2 months after using Denture 1
4. 4 weeks after using Denture 2
5. 2 months after using Denture 2

Denture 1 and 2 can be either conventionally made denture or denture made from partial digital method.

There are a total of 26 questions and each question has a scale from 0 to 100. Participants can then give a score.

0 - implies extremely not satisfied. 100 - implies extremely satisfied. The total minimum and maximum score for each attempt of this questionnaire is 0 and 2600 respectively. The higher the score, the higher the satisfaction from the patients on their denture., End of 2 months review of Denture 1 and Denture 2 respectively
Secondary Outcome Measures: Cost saving, To calculate the cost saved by the number of visits that the patients have to fulfill and also the material cost to see if one is significantly more affordable than the other., From start of fabrication to the issue of the denture to participants, up to 8 months|Time efficiency, To measure the time taken to fabricate the dentures using the two methods to see if one is significantly shorter than the other., From start of fabrication to the issue of the denture to participants, up to 8 months