Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Chapel Hill, North Carolina 27599


Purpose:

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 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.)


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


Study is Available At:


Original ID:

14-1811


NCT ID:

NCT02521935


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Suspended


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

99 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of North Carolina, Chapel Hill


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

The PI is deceased, looking for a new PI.


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Crosso


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

16


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:January 2017
Completion Date:January 2020
Completion Type:Anticipated
Primary Completion Date:January 2018
Primary Completion Type:Anticipated
Verification Date:September 2016
Last Changed Date:September 14, 2016
First Received Date:July 16, 2015

Study Outcomes

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

Study Interventions

Intervention Type:Device
Name:Complete traditional dentures
Description: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. Appoint
Arm Name:Complete traditional dentures
Other Name:complete conventional dentures
Intervention Type:Device
Name:Complete CADCAM dentures
Description: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 polymeri
Arm Name:Complete CADCAM dentures
Other Name:complete digital dentures

Study Arms

Study Arm Type:Active Comparator
Arm Name:Complete CADCAM dentures
Description:Complete maxillary/mandible dentures made with CADCAM (computer-aided design/computer-aided manufacturing) technology
Study Arm Type:Active Comparator
Arm Name:Complete traditional dentures
Description:Complete maxillary/mandible dentures made in the traditional manner.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of North Carolina, Chapel Hill
Agency Class:Other
Agency Type:Collaborator
Agency Name:Global Dental Science, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:WOELFEL JB, PAFFENBARGER GC, SWEENEY WT. CLINICAL EVALUATION OF COMPLETE DENTURES MADE OF 11 DIFFERENT TYPES OF DENTURE BASE MATERIALS. J Am Dent Assoc. 1965 May;70:1170-88.
PMID:14284642
Reference Type:Reference
Citation:Sato Y, Tsuga K, Akagawa Y, Tenma H. A method for quantifying complete denture quality. J Prosthet Dent. 1998 Jul;80(1):52-7.
PMID:9656178
Reference Type:Reference
Citation:Sato Y, Hamada S, Akagawa Y, Tsuga K. A method for quantifying overall satisfaction of complete denture patients. J Oral Rehabil. 2000 Nov;27(11):952-7.
PMID:11106986
Reference Type:Reference
Citation:Fenlon MR, Sherriff M, Walter JD. An investigation of factors influencing patients' use of new complete dentures using structural equation modelling techniques. Community Dent Oral Epidemiol. 2000 Apr;28(2):133-40.
PMID:10730722
Reference Type:Reference
Citation:Corrigan PJ, Basker RM, Farrin AJ, Mulley GP, Heath MR. The development of a method for functional assessment of dentures. Gerodontology. 2002 Jul;19(1):41-5.
PMID:12164238
Reference Type:Reference
Citation:Anastassiadou V, Naka O, Heath MR, Kapari D. Validation of indices for functional assessment of dentures. Gerodontology. 2002 Jul;19(1):46-52.
PMID:12164239
Reference Type:Reference
Citation:Allen PF, McMillan AS, Walshaw D. A patient-based assessment of implant-stabilized and conventional complete dentures. J Prosthet Dent. 2001 Feb;85(2):141-7.
PMID:11208203
Reference Type:Reference
Citation:Alfadda SA. The relationship between various parameters of complete denture quality and patients' satisfaction. J Am Dent Assoc. 2014 Sep;145(9):941-8. doi: 10.14219/jada.2013.48.
PMID:25170001
Reference Type:Reference
Citation:Infante L, Yilmaz B, McGlumphy E, Finger I. Fabricating complete dentures with CAD/CAM technology. J Prosthet Dent. 2014 May;111(5):351-5. doi: 10.1016/j.prosdent.2013.10.014. Epub 2014 Jan 23.
PMID:24461946
Reference Type:Reference
Citation:Parvizi A, Lindquist T, Schneider R, Williamson D, Boyer D, Dawson DV. Comparison of the dimensional accuracy of injection-molded denture base materials to that of conventional pressure-pack acrylic resin. J Prosthodont. 2004 Jun;13(2):83-9.
PMID:15210003
Reference Type:Reference
Citation:Darvell BW, Clark RK. The physical mechanisms of complete denture retention. Br Dent J. 2000 Sep 9;189(5):248-52. Review.
PMID:11048392
Reference Type:Reference
Citation:Bidra AS, Taylor TD, Agar JR. Computer-aided technology for fabricating complete dentures: systematic review of historical background, current status, and future perspectives. J Prosthet Dent. 2013 Jun;109(6):361-6. doi: 10.1016/S0022-3913(13)60318-2. Review.
PMID:23763779
Reference Type:Reference
Citation:Kattadiyil MT, Goodacre CJ, Baba NZ. CAD/CAM complete dentures: a review of two commercial fabrication systems. J Calif Dent Assoc. 2013 Jun;41(6):407-16.
PMID:23875432
Reference Type:Reference
Citation:Lee WS, Kim WC, Kim HY, Kim WT, Kim JH. Evaluation of different approaches for using a laser scanner in digitization of dental impressions. J Adv Prosthodont. 2014 Feb;6(1):22-9. doi: 10.4047/jap.2014.6.1.22. Epub 2014 Feb 14.
PMID:24605202
Reference Type:Reference
Citation:Goodacre CJ, Garbacea A, Naylor WP, Daher T, Marchack CB, Lowry J. CAD/CAM fabricated complete dentures: concepts and clinical methods of obtaining required morphological data. J Prosthet Dent. 2012 Jan;107(1):34-46. doi: 10.1016/S0022-3913(12)60015-8.
PMID:22230914
Reference Type:Reference
Citation:McCord JF. Contemporary techniques for denture fabrication. J Prosthodont. 2009 Feb;18(2):106-11. doi: 10.1111/j.1532-849X.2009.00439.x. Review.
PMID:19254299

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.