NCT03354715

Brief Summary

Comparing patient satisfaction and retention of upper complete denture fabricated using two different denture base materials, the first fabricated using rapid prototyping method while the second is following conventional methods.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 20, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 12, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

July 30, 2017

Last Update Submit

June 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    Patient Satisfaction Questionnaire using likert scale five points represent degree of satisfaction and compare the result to each other

    3 month

Secondary Outcomes (1)

  • Retention

    3 month

Study Arms (2)

Rapid prototyping Denture base

SHAM COMPARATOR

Complete Denture Using Rapid Prototyping method for fabrication of the complete denture depending on

Device: Rapid prototyping Denture base

Heat Cured Conventional Complete Denture

SHAM COMPARATOR

Complete Denture using heat cured Denture base using flasking and deflasking method

Device: Heat Cured Conventional Complete Denture

Interventions

The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology, which mainly depends on addition of layers of materials which would be polymerized using a light curing unit. It consists of a bath of photo polymerized liquid and ultraviolet unit for curing these layers, that would bond to each other till forming the full object. SLA has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.

Rapid prototyping Denture base

it is the main treatment for most of completely edentoulous Cases

Heat Cured Conventional Complete Denture

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ranging from 40-70 years.
  • Patients who can understand and respond to a written questionnaire in Arabic.
  • Cooperative patients

You may not qualify if:

  • Pathological changes of residual ridges.
  • Patients with debilitating systemic diseases.
  • Patients with xerostomia.
  • Patients with flabby and flat ridges.
  • Patients with allergy to acrylic resin
  • Patient with sever undercuts, or irregular bony exostosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 111789, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

July 30, 2017

First Posted

November 28, 2017

Study Start

April 20, 2017

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

June 12, 2018

Record last verified: 2018-06

Locations