Comparative Study of Denture Fabrication Techniques
Part of paid clinical trials in Newark, New Jersey.
- Sponsor
- Rutgers, The State University of New Jersey
- Study ID
- NCT07525011
- Status
- Not Yet Recruiting
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Conditions
- Complete Edentulism
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Traditional Complete Denture Fabrication — PROCEDUREConventional complete denture fabrication performed using standard clinical procedures, including preliminary impressions, custom tray fabrication, border molding, final impressions, record base and wax rim fabrication for recording occlusal vertical dimension and maxillomandibular relationship, tooth try-in appointment, denture processing, delivery, and post-insertion adjustments. All materials used are FDA-cleared and routinely utilized in standard dental practice.
- Easdent Digital Complete Denture Fabrication — PROCEDUREComplete denture fabrication performed using the Easdent digital complete denture workflow. This technique incorporates 3D-printed trays fabricated from FDA-cleared medical-grade denture tray or try-in denture materials. The trays are designed with standardized tooth positioning and retention features to facilitate recording of esthetics, occlusal vertical dimension, and maxillomandibular relationships using conventional impression materials. Subsequent clinical and laboratory procedures follow standard denture processing methods, including denture fabrication, delivery, and post-insertion adjustments.
Study Details
This study is a randomized, single-blinded clinical study conducted in the predoctoral clinic at Rutgers School of Dental Medicine. The purpose of this study is to compare a traditional complete denture fabrication technique with the Easdent digital complete denture workflow. The Easdent technique is a modification of the conventional method and utilizes FDA-approved materials and 3D-printed trays designed to record teeth position, jaw relations and impression information. Participants who require new dual-arch complete dentures will receive dentures fabricated using both techniques. The order of fabrication and delivery will be randomized. Clinical chair time, number of appointments, and total treatment time will be recorded. Patient-reported outcomes will be assessed using a modified OHIP-EDENT survey and preference questions after completion of both dentures. Student participants will also complete surveys evaluating learning experience and clinical usability. The study does not evaluate the safety or effectiveness of a drug or investigational device. All materials used are FDA-cleared and routinely used in clinical practice. The overall aim is to evaluate efficiency, patient satisfaction, and educational usability of the two denture fabrication workflows.
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- Apr 2026
- Primary completion
- Apr 30, 2028
- Completion
- May 30, 2028
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
Arms
- Experimental: Traditional Complete Denture FabricationParticipants receive complete dentures fabricated using the conventional complete denture workflow.
- Experimental: Easdent Digital Complete Denture FabricationParticipants receive complete dentures fabricated using the Easdent digital complete denture workflow utilizing 3D-printed trays.
Primary Outcome Measure
Total Clinical Chair Time per Denture Fabrication Method [ Time Frame: From initial impression appointment to final denture delivery (approximately 1-4 months) ]
Central Contacts
- Heba Elkassaby, DMD, MDSc, FACP973-972-6997
- Hua Zhu, DMD, PhD, MD973-972-4615
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rutgers, School of Dental Medicine | Newark | New Jersey | 07103 | Heba Elkassaby, BDS, DMD, MDSc, FACP (PRINCIPAL_INVESTIGATOR) Hua Zhu, DMD, PhD, MD (SUB_INVESTIGATOR) |