NCT01191073

Brief Summary

In the clinical trial, the Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) fabricated removable partial dentures (RPD's) are evaluated on casts and clinically compared with a traditional fabricated RPD for 50 consecutive patients. During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, … of both groups of dentures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

4.3 years

First QC Date

August 26, 2010

Last Update Submit

November 18, 2021

Conditions

Partially Edentulous Patients

Keywords

edentulous

Outcome Measures

Primary Outcomes (1)

  • fit of framework

    After casting "fit of the framework" between two identical reomvable partial dentures (same design, looks, material...) fabricated in a different way.

    9 months

Secondary Outcomes (2)

  • placement of RPD + control of placement

    3 to 5 days

  • re-evaluation of the RPD placement

    every 6 months, for 5 years

Study Arms (2)

CAD/CAM fabricated dentures

EXPERIMENTAL

group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)

Device: CAD/CAM fabricated RPD's

traditional fabricated dentures

ACTIVE COMPARATOR

group receiving traditional fabricated dentures (double blind)

Device: traditional fabricated RPD's

Interventions

CAD/CAM fabricated RPD'sDEVICE

group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)

CAD/CAM fabricated dentures
traditional fabricated RPD'sDEVICE

group receiving traditional fabricated dentures (double blind)

traditional fabricated dentures

Eligibility Criteria

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

You may qualify if:

  • patients in need of a classic removable partial denture (RPD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Lieve Van Zeghbroeck, MD, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2010

First Posted

August 30, 2010

Study Start

June 1, 2011

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

December 1, 2021

Record last verified: 2021-11

Locations

BE(1)