Implementation of Digital Workflow for Complete Dentures - A Crossover Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-99
SponsorNational Dental Centre, Singapore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

New denture wearers.

Patients require surgical interventions to correct ridge anatomy.

Patients with a history of maladaptation to denture use.

Patients with maxillofacial defects.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Sequence in receiving the fabricated dentures made using the conventional and partial digital method

    Procedure/Surgery

    Participants is not informed on the sequence they have been randomized hence they are not able to determine which denture is fabricated from which method. This would reduce bias when collecting the participants' responses in the satisfaction questionnaire during the review visits.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Receive conventionally made denture first then denture made from partial digital method.Other 1 intervention
Group B: Receive denture made from partial digital method first then conventionally made denture.Other 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
End of 2 months review of Denture 1 and Denture 2 respectively
2

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.

Time frame
End of 2 months review of Denture 1 and Denture 2 respectively

Secondary outcomes

1

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.

Time frame
From start of fabrication to the issue of the denture to participants, up to 8 months
2

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.

Time frame
From start of fabrication to the issue of the denture to participants, up to 8 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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