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Complete EdentulismNCT07525011

Comparative Study of Denture Fabrication Techniques

A study testing Traditional Complete Denture Fabrication and Easdent Digital Complete Denture Fabrication in people with Complete Edentulism, run by Rutgers, The State University of New Jersey at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Complete Edentulism
What is being tested?
Traditional Complete Denture Fabrication and Easdent Digital Complete Denture Fabrication
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
30 Apr 2026to 30 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site
  • Rutgers, School of Dental Medicine

    Newark, New Jersey, 07103

    Hua Zhu, DMD, PhD, MD, 9739724615, zhuhu1@sdm.rutgers.edu

    Heba Elkassaby, BDS, DMD, MDSc, FACP, 973-972-6997, hte9@sdm.rutgers.edu

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Traditional Complete Denture Fabrication, Easdent Digital Complete Denture Fabrication
Keywords
Complete Denture, Conventional Complete Denture, Digital Complete Denture, Edentulous Patients, Dental Education, Denture Workflow, Removable Prosthodontics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional Complete Denture FabricationProcedure or surgery

    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.

  • Easdent Digital Complete Denture FabricationProcedure or surgery

    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.

Study groups in NCT07525011
Study groupRoleWhat they receive
Traditional Complete Denture FabricationExperimentalParticipants receive complete dentures fabricated using the conventional complete denture workflow.
Receives: Procedure: Traditional Complete Denture Fabrication
Easdent Digital Complete Denture FabricationExperimentalParticipants receive complete dentures fabricated using the Easdent digital complete denture workflow utilizing 3D-printed trays.
Receives: Procedure: Easdent Digital Complete Denture Fabrication

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start30 Apr 2026 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07525011
Sponsor's protocol ID
Pro2025002520
Status last verified
Apr 2026
First submitted
12 Mar 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Traditional Complete Denture Fabrication and Easdent Digital Complete Denture Fabrication in people with Complete Edentulism, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heba Elkassaby, DMD, MDSc, FACP (973-972-6997, hte9@sdm.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Clinical Chair Time per Denture Fabrication Method (time frame: From initial impression appointment to final denture delivery (approximately 1-4 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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