NCT Number: NCT07525011
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Newark, New Jersey, 07103, United States
Heba Elkassaby, BDS, DMD, MDSc, FACP
CONTACT
Heba Elkassaby, BDS, DMD, MDSc, FACP
PRINCIPAL_INVESTIGATOR
Hua Zhu, DMD, PhD, MD
CONTACT
Hua Zhu, DMD, PhD, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From initial impression appointment to final denture delivery (approximately 1-4 months)
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.
Time frame: From enrollment to the end of treatment, an average of 4 months
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.
Time frame: From initial impression appointment to final denture delivery (approximately 1-4 months)
Total number of patient visits required to complete denture fabrication for each workflow from initial impression through final delivery and necessary adjustments.
Time frame: After completion and adaptation to both dentures (approximately 14-30 days post-delivery)
Participant selection of preferred denture (traditional vs. digital workflow) after experiencing both prostheses.
Time frame: From the enrollment to the end of treatment, at 4 months
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.
Time frame: From enrollment to the end of treatment, at 4 months
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.
Time frame: From enrollment to the end of treatment, at 4 months
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.
Contact information is provided by the study sponsor or research team.
Heba Elkassaby, DMD, MDSc, FACP
CONTACT
Hua Zhu, DMD, PhD, MD
CONTACT
Rutgers, The State University of New Jersey
Other
Comparative Study of Traditional Complete Denture Fabrication Technique and the Easdent Digital Complete Denture Fabrication Technique in a Predoctoral Dental Clinic
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