NCT03119753

Brief Summary

In this study we are going to compare dimensional accuracy of maxillary complete denture base fabricated by using rapid prototyping method and conventional method. We hypothesize that both techniques do not significantly differ from each other

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 11, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 10, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

1 month

First QC Date

April 11, 2017

Last Update Submit

April 14, 2017

Conditions

Keywords

Rapid Prototyping techniquecomplete denture

Outcome Measures

Primary Outcomes (1)

  • dimensional accuracy of complete denture

    dimensional accuracy of complete denture will be measured using digital caliper

    1 month

Study Arms (2)

Group R

EXPERIMENTAL

Rapid Prototyping method of fabrication of complete denture: the master casts will be scanned using DENTAL WINGS eco-scan 3, using laser technology for scanning, after spraying the stainless steel pins with scanning spray to be recorded into the denture base. Virtual model will be obtained for fabrication of denture bases. Denture base will be designed and modified on the virtual model, then it will be printed using ZENITH-3D Printer using Urethane acrylate oligomer based photo-polymerized resin.

Device: Rapid Prototyping method of fabrication of complete denture

Group C

ACTIVE COMPARATOR

Conventional method of fabrication of complete denture: Self-cured acrylic resin trial denture bases will be constructed on the obtained master casts, then processing of the final denture bases by conventional clamping method cured by long curing cycle (74º C for 8 hours) using heat-cured poly-methyl methacrylate (PMMA) resin material. The position of the pins will be recorded into the denture bases so that the linear changes could be measured.

Device: Conventional method of fabrication of complete denture

Interventions

For Rapid Prototyping Method of fabrication of complete denture : the master casts will be scanned using DENTAL WINGS eco-scan 3, using laser technology for scanning, after spraying the stainless steel pins with scanning spray to be recorded into the denture base. Virtual model will be obtained for fabrication of denture bases. Denture base will be designed and modified on the virtual model, then it will be printed using ZENITH-3D Printer using Urethane acrylate oligomer based photo-polymerized resin.

Group R

For Conventional Method of fabrication of complete denture: Self-cured acrylic resin trial denture bases will be constructed on the obtained master casts, then processing of the final denture bases by conventional clamping method cured by long curing cycle (74º C for 8 hours) using heat-cured poly-methyl methacrylate (PMMA) resin material. The position of the pins will be recorded into the denture bases so that the linear changes could be measured.

Group C

Eligibility Criteria

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

You may qualify if:

  • Age ranging from 40-70 years.
  • Class I Angle's ridge relationship.
  • Literate patients are able to understand and respond to a written questionnaire in Arabic.
  • Cooperative patients with no history psychological diseases.
  • A period of at least six months should elapse from the last extraction.

You may not qualify if:

  • Pathological changes of residual ridges.
  • Patients with debilitating systemic diseases.
  • Patients with xerostomia.
  • Patients with temporo-mandibular joint disorders or systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
  • Patients with macroglossia or microstomia
  • Patients with flabby and flat ridges.
  • Patients with allergy to acrylic resin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 19, 2017

Study Start

June 10, 2017

Primary Completion

July 10, 2017

Study Completion

September 10, 2017

Last Updated

April 19, 2017

Record last verified: 2017-04