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Clinical Success, Oral Health-Related Quality of Life, and Relationship Between Maximum Masticatory Force and Denture Wear in Complete Dentures Fabricated by Additive Manufacturing Under Digital and Hybrid Workflows: A Prospective Randomized Crossover Clinical Trial
Led by Universidad de Especialidades Espiritu Santo · Updated on 2026-06-04
20
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the clinical performance and oral health-related quality of life of complete dentures made by two different 3D printing methods—digital and hybrid workflows—in adults without teeth (edentulous). This randomized crossover trial compares dentures made by direct digital scanning and 3D printing versus those made by conventional impressions combined with digital design and additive manufacturing. The study aims to assess denture success, quality of life impact, and the relationship between chewing force and denture wear in patients aged 50 to 80 years. Participants receive two sets of complete dentures in a random order: one set made with the digital workflow and another with the hybrid workflow. The digital workflow involves three appointments including intraoral scanning, try-in of a 3D-printed prototype, and delivery of the final denture. The hybrid workflow includes five appointments starting with conventional impressions, wax try-in, digitization, and final 3D-printed denture delivery. Each denture set is worn for 2 months before switching to the other, with total crossover follow-up lasting about 4 months, followed by 12 months of wear monitoring of the second denture set. During the study, participants complete questionnaires assessing oral health quality of life at four key timepoints and undergo evaluations of denture fit, stability, chewing force using digital occlusal analysis, and denture wear tracked via 3D digital scans. The research team monitors clinical adjustments needed and correlates chewing force with denture surface wear over 12 months. The entire participation period is approximately 16 months, including crossover and long-term follow-up phases.
CONDITIONS
Brief Title
Clinical Performance and Quality of Life of 3D-Printed Complete Dentures Under Digital vs Hybrid Workflows: A Randomized Crossover Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completely edentulous (bimaxillary)
- Age between 50 and 80 years
- Able to understand and sign informed consent
- No cognitive or psychological deficits that interfere with study participation
You will not qualify if you...
- Unimaxillary edentulism
- Presence of Kelly syndrome
- Presence of flabby tissue on alveolar ridges
- No prior experience with complete dentures
- Chronic motor disorders that may compromise prosthetic function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are assessed to confirm they are completely edentulous, aged 50-80 years, and meet other inclusion criteria.
Duration - Up to 5 clinical appointments over initial weeks
Participants receive either digital workflow or hybrid workflow complete dentures fabricated through respective clinical appointments.
3 appointments for digital workflow or 5 appointments for hybrid workflow
Duration - 2 months
Participants wear the first complete denture set and attend control visits to assess oral health-related quality of life, clinical success, masticatory force, and denture wear.
1 control visit at 2 months (in-person)
Duration - Up to 5 clinical appointments over initial weeks
Participants cross over to the alternate denture fabrication workflow and receive the second complete denture set fabricated through respective clinical appointments.
3 appointments for digital workflow or 5 appointments for hybrid workflow
Duration - 2 months
Participants wear the second complete denture set and attend control visits to assess oral health-related quality of life, clinical success, masticatory force, and denture wear.
1 control visit at 2 months (in-person)
Duration - 12 months
Participants undergo longitudinal monitoring of denture wear and maximum masticatory force over 12 months after insertion of the second denture set.
Scheduled follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Clínica Odontológica - Universidad de Especialidades Espíritu Santo (UEES)
Samborondón, Guayas, Ecuador
Actively Recruiting
Research Team
P
Pablo Benitez, phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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