Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences

Study Overview
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Brief Summary
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Purpose: To compare complete denture outcomes between conventional and digital denture fabrication processes. Participants: Sixteen edentulous adult patients in the University of North Carolina School of Dentistry Student Clinic who are seeking removable complete dentures. Procedures (methods): Two complete sets of dentures will be fabricated for each subject: one using the conventional process (A) and the other using a digital process (B). Variability will be assessed by the research team, the treating dental students, an independent prosthodontist, and the patients through quantitative measures. Case selection and results analysis will be evaluated with recognition of the Prosthodontic Diagnostic Index.

Detailed Description
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Rationale for Study Design An AB/BA (conventional=A, digital=B) crossover design with no wash-out period is flawed for this study, and its weakness is the potential for a carryover effect (benefits or risks associated with treatment A carry over to treatment B). A wash-out period is not feasible for this study because it would require the patient-subjects to suspend use of their dentures for the duration of the wash-out period. The Investigators have decided to conduct the study using the ABB/BAA crossover design, which does not require a wash-out period and will permit testing and discounting of a possible carryover effect. In addition, this design is more appropriate for a small sample size than the AB/BA design. The investigators are adding to the scant literature on digital dentures, information that has never before been studied - the retention, aesthetics, and stability of digital dentures compared to conventional dentures. Additionally, the investigators will have longitudinal data on these characteristics regarding digital dentures. If the Functional Assessment of Dentures (FAD) and the patient evaluation show positive results for the digital dentures, this could lead to increased use of the Computer -Aided Design/ Computer -Aided Manufacturing (CADCAM) fabrication method which, in turn, would allow greater numbers of people to benefit from the advantages of the digital dentures as described earlier in this application (e.g., a better fit, fewer visits with less time in the chair, less biofilm formation, etc.)

Official Title
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Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences

Conditions
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Mouth, Edentulous

Intervention / Treatment
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* Device: Complete traditional dentures
* Device: Complete CADCAM dentures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: UNC School of Dentistry Student Clinic patients requiring maxillary and mandibular complete dentures Ages 18 to 99, inclusive Able to read, speak, and understand English Without natural tooth or implant supported overdentures Edentulous in both jaws for at least 6 months Any Prosthodontic Diagnostic Index (PDI) type with a preference given to Types 1-3 Exclusion Criteria: Non-registered patient in UNC School of Dentistry student clinics Patient not able or unwilling to give consent Subject had extractions within last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Complete traditional dentures<br>Complete maxillary/mandible dentures made in the traditional manner. | Device: Complete traditional dentures<br>* Arm 1-Standard Treatment Sequence for Traditional Removable Dentures in a Dental School Clinic (9 Appointments): Appointment 1: Examination & diagnosis & initial impressions. Appointment 2: Secondary impressions. Appointment 3: Secondary or definitive impressions (Often 2 appointments are needed to border mold and impression) Appointment 4: Maxillo-mandibular jaw relation records (both centric and vertical relation). Tooth selection. Appointment 5: Wax-trial denture try-in. Appointment 6: Insertion and instructions for care of definitive prostheses. Appointments 7-9 Post adjustments<br>* Other names: complete conventional dentures;|
| Active Comparator: Complete CADCAM dentures<br>Complete maxillary/mandible dentures made with CADCAM (computer-aided design/computer-aided manufacturing) technology | Device: Complete CADCAM dentures<br>* Arm 2-Standard Treatment Sequence for Digital Dentures in a Dental School Clinic (5 appointments): Appointment 1: Exam, diagnosis, & tray selection (begin impressions) Appointment 2: Definitive impressions and Maxillomandibula relations Appointment 3: Wax-trial arrangement Appointment 4: Insertion and instructions for care of definitive prosthesis Appointment 5: Post adjustment/s (Less post insertion adjustments are anticipated due to CADCAM milling of the denture base and less polymerization shrinkage<br>* Other names: complete digital dentures;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the overall comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures | evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD= Functional Assessment of Dentures) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures | evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD= Functional Assessment of Dentures) | baseline = 4 weeks | 
| comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures | evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD) | 3 months | 
| comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures | evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD) | 6 months | 
| comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures | evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD) | 1 year | 
| comparison of patient satisfaction between digital dentures and traditional dentures | patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale | baseline = 4 weeks | 
| comparison of patient satisfaction between digital dentures and traditional dentures | patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale | 3 months | 
| comparison of patient satisfaction between digital dentures and traditional dentures | patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale | 6 months | 
| comparison of patient satisfaction between digital dentures and traditional dentures | patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale | 1 year | 
| comparison of patient satisfaction between digital dentures and traditional dentures | patient satisfaction survey consisting of 12 items organized into 5 subscales (not at all satisfied, not very satisfied, reasonably satisfied, very satisfied, totally satisfied) and responses are based on a Likert scale | 2 year | 
| bite force comparison between digital dentures and traditional dentures | using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement | baseline = 4 weeks | 
| bite force comparison between digital dentures and traditional dentures | using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement | 3 months | 
| bite force comparison between digital dentures and traditional dentures | using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement | 6 months | 
| bite force comparison between digital dentures and traditional dentures | using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement | 1 year | 
| bite force comparison between digital dentures and traditional dentures | using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement | 2 year |