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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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.)

Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: the overall comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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)
• 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)
• 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)
• 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)
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: July 16, 2015
Date Started: January 2017
Date Completion: January 2020
Last Updated: April 25, 2017
Last Verified: April 2017