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

April 25, 2017 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.)

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina School of Dentistry Student Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Complete traditional dentures
Complete maxillary/mandible dentures made in the traditional manner.
Device: Complete traditional dentures

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

Other Names:
  • complete conventional dentures
Active Comparator: Complete CADCAM dentures
Complete maxillary/mandible dentures made with CADCAM (computer-aided design/computer-aided manufacturing) technology
Device: Complete CADCAM dentures

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

Other Names:
  • complete digital dentures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the overall comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures
Time Frame: 2 years
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
Time Frame: baseline = 4 weeks
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
Time Frame: 3 months
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
Time Frame: 6 months
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
Time Frame: 1 year
evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD)
1 year
comparison of patient satisfaction between digital dentures and traditional dentures
Time Frame: baseline = 4 weeks
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
Time Frame: 3 months
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
Time Frame: 6 months
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
Time Frame: 1 year
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
Time Frame: 2 year
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
Time Frame: baseline = 4 weeks
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
Time Frame: 3 months
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
Time Frame: 6 months
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
Time Frame: 1 year
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
Time Frame: 2 year
using gnathometer assessment, investigators will record the force (on a 0-10 scale) during dislodgement
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Global Dental Science, LLC

Investigators

  • Principal Investigator: Robert F Wright, DDS FACP, Professor and Chair, Dept. of Prosthodontics UNC School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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