Comparative Study of Denture Fabrication Techniques
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About
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.
Full 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.
Enrollment
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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.
Trial design
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Interventional model
Masking
20 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Heba Elkassaby, DMD, MDSc, FACP; Hua Zhu, DMD, PhD, MD
Data sourced from clinicaltrials.gov
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