Implementation of Digital Workflow for Complete Dentures - A Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Patients' Oral Health Quality of Life
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with complete edentulism requiring complete denture treatments.
- •Prior denture experience.
- •Above the age of 21 years.
- •Medically fit (ASA classification of physical status I-III);
- •Able to write/read English or Chinese well.
排除标准
- •New denture wearers.
- •Patients require surgical interventions to correct ridge anatomy.
- •Patients with a history of maladaptation to denture use.
- •Patients with maxillofacial defects.
- •Patients unable to response to the English/Chinese questionnaires.
- •Patients with enlarged tuberosity, minimal bone resorption resulting in limited restorative space
- •Patients with enlarged tori
- •Patients with flabby ridge
- •Patients with severely resorbed ridges
- •Patients with severe skeletal relationship discrepancy
研究组 & 干预措施
Receive conventionally made denture first then denture made from partial digital method.
Participants will be receiving their Denture 1 made from conventional method first and provide feedback at the 1-month and 2-month Denture 1 post-issue review visits.
Participants will then return the Denture 1 to the attending clinician and receive the Denture 2 made from partial digital method and provide feedback at the 1-month and 2-month post-issue Denture 2 review visits.
干预措施: Sequence in receiving the fabricated dentures made using the conventional and partial digital method (Procedure)
Receive denture made from partial digital method first then conventionally made denture.
Participants will be receiving their Denture 1 made from partial digital method first and provide feedback at the 1-month and 2-month Denture 1 post-issue review visits.
Participants will then return the Denture 1 to the attending clinician and receive the Denture 2 made from conventional method and provide feedback at the 1-month and 2-month post-issue Denture 2 review visits.
干预措施: Sequence in receiving the fabricated dentures made using the conventional and partial digital method (Procedure)
结局指标
主要结局
Patients' Oral Health Quality of Life
时间窗: End of 2 months review of Denture 1 and Denture 2 respectively
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.
Patients' Denture Satisfaction
时间窗: End of 2 months review of Denture 1 and Denture 2 respectively
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.
次要结局
- Cost saving(From start of fabrication to the issue of the denture to participants, up to 8 months)
- Time efficiency(From start of fabrication to the issue of the denture to participants, up to 8 months)