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

NCT02521935 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-04-27

No results posted yet for this study

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.

Conditions

  • Mouth, Edentulous

Interventions

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

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

Sponsors & Collaborators

  • Global Dental Science, LLC

    collaborator UNKNOWN

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-01-31
Completion
2020-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02521935 on ClinicalTrials.gov