Comparative Study of Denture Fabrication Techniques

NCT07525011 | Not Yet Recruiting

• 1 other identifier: Pro2025002520
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complete Edentulism

Keywords

Complete Denture; Conventional Complete Denture; Digital Complete Denture; Edentulous Patients; Dental Education; Denture Workflow; Removable Prosthodontics

Outcome Measures

Primary Outcomes (1)

• Total Clinical Chair Time per Denture Fabrication Method

  Total accumulated clinical chair time (in minutes) required to complete denture fabrication for each workflow, measured from initial impression appointment through final delivery and necessary adjustments.

  From initial impression appointment to final denture delivery (approximately 1-4 months)

Secondary Outcomes (1)

• Patient-Reported Oral Health-Related Quality of Life (Modified Oral Health Impact Profile for Edentulous Adults Score)

  From enrollment to the end of treatment, an average of 4 months

Other Outcomes (5)

• Number of Clinical Visits per Fabrication Method

  From initial impression appointment to final denture delivery (approximately 1-4 months)

• Patient Denture Preference

  After completion and adaptation to both dentures (approximately 14-30 days post-delivery)

• Student-Reported Learning Difficulty

  From the enrollment to the end of treatment, at 4 months

Study Arms (2)

Traditional Complete Denture Fabrication

EXPERIMENTAL

Participants receive complete dentures fabricated using the conventional complete denture workflow.

Procedure: Traditional Complete Denture Fabrication

Easdent Digital Complete Denture Fabrication

EXPERIMENTAL

Participants receive complete dentures fabricated using the Easdent digital complete denture workflow utilizing 3D-printed trays.

Procedure: Easdent Digital Complete Denture Fabrication

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.

Traditional Complete Denture Fabrication

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.

Easdent Digital Complete Denture Fabrication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Requiring new dual-arch complete dentures.
• Willing and able to attend for all required study appointments, including delivery and follow-up visits.

You may not qualify if:

• Requiring only single-arch complete dentures.
• Presence of severe medical conditions that would preclude attendance at multiple prosthodontic appointments.
• Active, untreated oral mucosal disease that would prevent impression making or denture fabrication.
• Severely resorbed edentulous ridges.
• Unable or unwilling to attend for all scheduled study visits or follow-up appointments.
• Unable to comply with instructions necessary for denture treatment or study procedures.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers, School of Dental Medicine

Newark, New Jersey, 07103, United States

Location

Study Officials

• Heba Elkassaby, DMD, MDSc, FACP

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heba Elkassaby, DMD, MDSc, FACP

CONTACT

973-972-6997; hte9@sdm.rutgers.edu

Hua Zhu, DMD, PhD, MD

CONTACT

973-972-4615; zhuhu1@sdm.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed which denture corresponds to the traditional fabrication workflow or the Easdent digital workflow at the time of evaluation. Student providers, supervising faculty, and investigators will be aware of the fabrication method used. No other parties are masked.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses a randomized crossover design. Each enrolled participant will receive two sets of complete dentures fabricated using two different workflows: the conventional complete denture technique and the Easdent digital complete denture workflow. The order in which the dentures are fabricated and delivered will be randomized to minimize sequence effects. After both dentures are completed and delivered, participants will evaluate each prosthesis following an adaptation period. Outcomes related to clinical efficiency and participant-reported measures will be collected for both workflows within the same individual, allowing each participant to serve as their own control.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 13, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)