Implementation of Digital Workflow for Complete Dentures - A Crossover Study

NCT06457321 | Not Yet Recruiting

• 1 other identifier: 370-2022
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complete Edentulism

Keywords

Complete edentulism; Complete denture; Digital Denture; Computer aided design; Computer aided manufacturing; CAD; CAM

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Receive conventionally made denture first then denture made from partial digital method.

OTHER

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.

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

Receive denture made from partial digital method first then conventionally made denture.

OTHER

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.

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

Interventions

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

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.

Receive conventionally made denture first then denture made from partial digital method.; Receive denture made from partial digital method first then conventionally made denture.

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Dental Centre, Singapore: lead

MeSH Terms

Interventions

Base Sequence

Intervention Hierarchy (Ancestors)

Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Central Study Contacts

Danielle Tan

CONTACT

64352068; danielle.tan.l.l@ndcs.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into 2 groups which receive dentures fabricated by two different methods. Group 1: Participants receive denture made from Conventional method, followed by denture made from partial digital method Group 2: Participants receive denture made from partial digital method, followed by denture made from conventional method

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: June 13, 2024
• Study Start: October 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share