Clinical trial NCT02521935: Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences
Official title: Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mouth, Edentulous
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Global Dental Science, LLC
First posted: 2015-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.)

Eligibility criteria: Inclusion Criteria:

1. UNC School of Dentistry Student Clinic patients requiring maxillary and mandibular complete dentures
2. Ages 18 to 99, inclusive
3. Able to read, speak, and understand English
4. Without natural tooth or implant supported overdentures
5. Edentulous in both jaws for at least 6 months
6. Any Prosthodontic Diagnostic Index (PDI) type with a preference given to Types 1-3

Exclusion Criteria:

1. Non-registered patient in UNC School of Dentistry student clinics
2. Patient not able or unwilling to give consent
3. Subject had extractions within last 6 months

Primary outcomes:
measure: the overall comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
timeFrame: 2 years
Secondary outcomes:
measure: comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
timeFrame: baseline = 4 weeks
measure: comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
timeFrame: 3 months
measure: comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
timeFrame: 6 months
measure: comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
timeFrame: 1 year
measure: comparison of patient satisfaction between digital dentures and traditional dentures
timeFrame: baseline = 4 weeks
measure: comparison of patient satisfaction between digital dentures and traditional dentures
timeFrame: 3 months
measure: comparison of patient satisfaction between digital dentures and traditional dentures
timeFrame: 6 months
measure: comparison of patient satisfaction between digital dentures and traditional dentures
timeFrame: 1 year
measure: comparison of patient satisfaction between digital dentures and traditional dentures
timeFrame: 2 year
measure: bite force comparison between digital dentures and traditional dentures
timeFrame: baseline = 4 weeks
measure: bite force comparison between digital dentures and traditional dentures
timeFrame: 3 months
measure: bite force comparison between digital dentures and traditional dentures
timeFrame: 6 months
measure: bite force comparison between digital dentures and traditional dentures
timeFrame: 1 year
measure: bite force comparison between digital dentures and traditional dentures
timeFrame: 2 year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina School of Dentistry Student Clinics
state: North Carolina
Study officials:
affiliation: Professor and Chair, Dept. of Prosthodontics UNC School of Dentistry
name: Robert F Wright, DDS FACP
role: PRINCIPAL_INVESTIGATOR
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