Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | May 2016 |
| End Date: | May 2019 |
| Contact: | Gidgetta Jenkins |
| Phone: | 919-537-3968 |
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.
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.
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.)
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.)
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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Phone: 919-537-3968
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