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 — PROCEDURE
    Conventional 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 — PROCEDURE
    Complete 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 Fabrication
    Participants receive complete dentures fabricated using the conventional complete denture workflow.
  • Experimental: Easdent Digital Complete Denture Fabrication
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers, School of Dental MedicineNewarkNew Jersey07103
Hua Zhu, DMD, PhD, MD
9739724615
Heba Elkassaby, BDS, DMD, MDSc, FACP
973-972-6997
Heba Elkassaby, BDS, DMD, MDSc, FACP (PRINCIPAL_INVESTIGATOR)
Hua Zhu, DMD, PhD, MD (SUB_INVESTIGATOR)

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