NCT02521935

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

July 16, 2015

Last Update Submit

April 25, 2017

Conditions

Mouth, Edentulous

Outcome Measures

Primary Outcomes (1)

  • the overall comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures

    evaluate functional assessment of digitally fabricated dentures to traditionally fabricated dentures (FAD= Functional Assessment of Dentures)

    2 years

Secondary Outcomes (14)

  • comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures

    baseline = 4 weeks

  • comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures

    3 months

  • comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures

    6 months

  • comparison of functional assessment of digitally fabricated dentures to traditionally fabricated dentures

    1 year

  • comparison of patient satisfaction between digital dentures and traditional dentures

    baseline = 4 weeks

  • +9 more secondary outcomes

Study Arms (2)

Complete traditional dentures

ACTIVE COMPARATOR

Complete maxillary/mandible dentures made in the traditional manner.

Device: Complete traditional dentures

Complete CADCAM dentures

ACTIVE COMPARATOR

Complete maxillary/mandible dentures made with CADCAM (computer-aided design/computer-aided manufacturing) technology

Device: Complete CADCAM dentures

Interventions

Complete traditional denturesDEVICE

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

Also known as: complete conventional dentures
Complete traditional dentures
Complete CADCAM denturesDEVICE

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

Also known as: complete digital dentures
Complete CADCAM dentures

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina School of Dentistry Student Clinics

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (16)

  • McCord JF. Contemporary techniques for denture fabrication. J Prosthodont. 2009 Feb;18(2):106-11. doi: 10.1111/j.1532-849X.2009.00439.x.

    PMID: 19254299BACKGROUND

  • 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: 22230914BACKGROUND

  • 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: 24605202BACKGROUND

  • 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: 23875432BACKGROUND

  • 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.

    PMID: 23763779BACKGROUND

  • Darvell BW, Clark RK. The physical mechanisms of complete denture retention. Br Dent J. 2000 Sep 9;189(5):248-52. doi: 10.1038/sj.bdj.4800734.

    PMID: 11048392BACKGROUND

  • 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. doi: 10.1111/j.1532-849X.2004.04014.x.

    PMID: 15210003BACKGROUND

  • 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: 24461946BACKGROUND

  • 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: 25170001BACKGROUND

  • 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. doi: 10.1067/mpr.2001.113214.

    PMID: 11208203BACKGROUND

  • Anastassiadou V, Naka O, Heath MR, Kapari D. Validation of indices for functional assessment of dentures. Gerodontology. 2002 Jul;19(1):46-52. doi: 10.1111/j.1741-2358.2002.00046.x.

    PMID: 12164239BACKGROUND

  • 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. doi: 10.1111/j.1741-2358.2002.00041.x.

    PMID: 12164238BACKGROUND

  • 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. doi: 10.1034/j.1600-0528.2000.028002133.x.

    PMID: 10730722BACKGROUND

  • 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. doi: 10.1046/j.1365-2842.2000.00579.x.

    PMID: 11106986BACKGROUND

  • Sato Y, Tsuga K, Akagawa Y, Tenma H. A method for quantifying complete denture quality. J Prosthet Dent. 1998 Jul;80(1):52-7. doi: 10.1016/s0022-3913(98)70091-5.

    PMID: 9656178BACKGROUND

  • 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. doi: 10.14219/jada.archive.1965.0208. No abstract available.

    PMID: 14284642BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Robert F Wright, DDS FACP

    Professor and Chair, Dept. of Prosthodontics UNC School of Dentistry

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

August 13, 2015

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2020

Last Updated

April 27, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)