Comparative Study of Denture Fabrication Techniques
ConditionComplete Edentulism
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Traditional Complete Denture Fabrication
Procedure/SurgeryConventional 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/SurgeryComplete 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Traditional Complete Denture FabricationExperimental treatment 1 intervention
Group B: Easdent Digital Complete Denture FabricationExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
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)
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 enrollment to the end of treatment, an average of 4 monthsOther outcomes
1
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.
Time frame
From initial impression appointment to final denture delivery (approximately 1-4 months)2
Patient Denture Preference
Participant selection of preferred denture (traditional vs. digital workflow) after experiencing both prostheses.
Time frame
After completion and adaptation to both dentures (approximately 14-30 days post-delivery)3
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.
Time frame
From the enrollment to the end of treatment, at 4 months4
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.
Time frame
From enrollment to the end of treatment, at 4 monthsSponsors and contacts
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Source ClinicalTrials.gov
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