Comparative Study of Denture Fabrication Techniques

Comparative Study of Traditional Complete Denture Fabrication Technique and the Easdent Digital Complete Denture Fabrication Technique in a Predoctoral Dental Clinic

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Complete Edentulism
• Intervention / Treatment: Procedure: Traditional Complete Denture Fabrication; Procedure: Easdent Digital Complete Denture Fabrication

Detailed Description

Complete dentures remain a common treatment for fully edentulous patients. The traditional complete denture fabrication workflow requires multiple clinical visits, including preliminary impressions, custom tray fabrication, border molding, final impressions, record base and wax rim fabrication, jaw relation records, tooth try-in, and final delivery. This process is technique-sensitive, time-intensive, and may require numerous patient appointments. In predoctoral dental education settings, the complexity of the workflow can also contribute to variability in clinical efficiency and student learning experience. The Easdent digital complete denture workflow is a modification of the conventional technique. It incorporates 3D-printed trays fabricated from FDA-cleared medical-grade denture tray or try-in denture materials. These trays are designed with features similar to try-in dentures, including standardized tooth positioning and idealized intercuspation between maxillary and mandibular arches. Retention holes are incorporated to allow the use of conventional impression materials in a manner similar to traditional stock trays. The trays are produced in multiple standardized sizes to accommodate variation in jaw dimensions. The workflow is intended to streamline the recording of esthetics (such as midline and horizontal reference lines), occlusal vertical dimension, and maxillomandibular relationships while maintaining compatibility with conventional denture processing techniques. This study is designed to compare the traditional complete denture workflow with the Easdent digital complete denture workflow in a predoctoral clinical environment. The investigation focuses on efficiency, patient-reported outcomes, and educational usability rather than safety or effectiveness of a drug or investigational device. All materials used in this study are FDA-cleared and routinely used in standard dental practice. Participants who require new dual-arch complete dentures will receive dentures fabricated using both workflows. The order of fabrication and delivery will be randomized to reduce sequencing bias. The study uses a single-blinded design in which participants are not informed which denture corresponds to which fabrication method at the time of evaluation. After completion and adjustment of both dentures, participants will complete standardized patient-reported surveys and indicate their preference. Clinical efficiency metrics include the number of appointments required, chair time per visit, and total treatment duration associated with each workflow. These data are recorded prospectively by trained student researchers under faculty supervision. Standardization procedures, including calibration sessions and training lectures, are implemented to reduce inter-operator variability. Patient-reported outcomes are assessed using a modified OHIP-EDENT 19 questionnaire, supplemented with additional items evaluating esthetic satisfaction and overall satisfaction. Surveys are administered after an adaptation period following delivery of both dentures to allow patients to assess comfort, function, and esthetics. Preference data are collected after participants have experienced both prostheses. In addition to patient outcomes, the study evaluates the educational impact of the two workflows. Student researchers complete structured surveys assessing perceived learning difficulty, procedural complexity, and overall workflow usability. This component is intended to evaluate feasibility and integration of the modified workflow within a predoctoral dental curriculum. The anticipated risks are consistent with routine complete denture treatment and include temporary mucosal soreness, minor discomfort during impression procedures, temporary speech adaptation, and the potential need for post-insertion adjustments. No additional risks beyond standard denture treatment are introduced by study participation. The study is considered minimal risk. The findings of this study may provide data regarding clinical efficiency, patient-centered outcomes, and educational feasibility of a modified denture fabrication workflow in an academic clinical setting. Results may inform decisions regarding curriculum design and clinical workflow optimization in complete denture therapy.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba Elkassaby, DMD, MDSc, FACP; Phone Number: 973-972-6997; Email: hte9@sdm.rutgers.edu
• Study Contact Backup: Name: Hua Zhu, DMD, PhD, MD; Phone Number: 973-972-4615; Email: zhuhu1@sdm.rutgers.edu

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers, School of Dental Medicine
      • Contact: Hua Zhu, DMD, PhD, MD; Phone Number: 9739724615; Email: zhuhu1@sdm.rutgers.edu
      • Contact: Heba Elkassaby, BDS, DMD, MDSc, FACP; Phone Number: 973-972-6997; Email: hte9@sdm.rutgers.edu
      • Principal Investigator: Heba Elkassaby, BDS, DMD, MDSc, FACP
      • Sub-Investigator: Hua Zhu, DMD, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional Complete Denture Fabrication; Participants receive complete dentures fabricated using the conventional complete denture workflow.	Procedure: Traditional Complete Denture Fabrication; 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.
Experimental: Easdent Digital Complete Denture Fabrication; Participants receive complete dentures fabricated using the Easdent digital complete denture workflow utilizing 3D-printed trays.	Procedure: Easdent Digital Complete Denture Fabrication; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Oral Health-Related Quality of Life (Modified Oral Health Impact Profile for Edentulous Adults Score)	Patient-reported outcomes will be measured using a modified version of the Oral Health Impact Profile for Edentulous Adults 19 questionnaire. This modified instrument consists of 22 items: the original 19 OHIP-EDENT questions plus 3 additional items assessing esthetic and overall satisfaction. Each item is rated on a 5-point Likert scale, where 1 represents the minimum (poorest) score and 5 represents the maximum (best) score. Total scores are calculated by summing the responses to all 22 items, resulting in a possible score range from 22 (minimum) to 110 (maximum). A higher score indicates a better outcome (higher quality of life). Domain-specific subscores will also be calculated and reported.	From enrollment to the end of treatment, an average of 4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Clinical Visits per Fabrication Method	Total number of patient visits required to complete denture fabrication for each workflow from initial impression through final delivery and necessary adjustments.	From initial impression appointment to final denture delivery (approximately 1-4 months)
Patient Denture Preference	Participant selection of preferred denture (traditional vs. digital workflow) after experiencing both prostheses.	After completion and adaptation to both dentures (approximately 14-30 days post-delivery)
Student-Reported Learning Difficulty	Student-Reported Learning Difficulty will be assessed using two individual items measuring the perceived difficulty of learning the Traditional technique versus the Easdent workflow. Each item is rated on a 5-point Likert scale (1 = "Very Easy" to 5 = "Very Difficult"). Scores for each technique range from a minimum of 1 (least difficult) to a maximum of 5 (most difficult). A higher score indicates a worse outcome (greater learning difficulty). Results will be reported separately for each fabrication workflow.	From the enrollment to the end of treatment, at 4 months
Student-Reported Clinical Usability	Student-Reported Clinical Ease of Use will be assessed using two individual items measuring the perceived difficulty of clinically applying the Traditional technique versus the Easdent workflow. Each item is rated on a 5-point Likert scale (1 = "Very Easy" to 5 = "Very Difficult"). Scores for each technique range from a minimum of 1 (least difficult) to a maximum of 5 (most difficult). A higher score indicates a worse outcome (greater difficulty in clinical usage). Results will be reported separately for each fabrication workflow.	From enrollment to the end of treatment, at 4 months
Student Preference and Perceived Efficiency of Denture Fabrication Workflows	Student preference and perceived efficiency will be assessed using a 7-item survey comparing the Traditional technique and the Easdent workflow. Each item asks the participant to select their preferred or most efficient method (e.g., "Traditional," "Easdent," or "Both/No Preference"). Results for each item will be reported as the number (frequency) and percentage of participants who selected each category. There is no numerical scale or total score for this measure. A higher percentage of participants selecting a specific workflow indicates a more favorable outcome for that method regarding perceived efficiency, learning preference, and clinical utility.	From enrollment to the end of treatment, at 4 months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Heba Elkassaby, DMD, MDSc, FACP, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Complete Denture; Removable Prosthodontics; Dental Education; Conventional Complete Denture; Digital Complete Denture; Edentulous Patients; Denture Workflow
• Other Study ID Numbers: Pro2025002520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No