NCT06588140

Brief Summary

Twenty completely edentulous patients with old, removable dentures with ill-fitting maxillary dentures, proper vertical dimension, and proper occlusion will be recruited for this trial. They will be rehabilitated with duplicated complete dentures manufactured by conventional and two different 3D-printed CAD-CAM Complete Removable Dentures techniques. Outcomes will be evaluated, including denture retention, which will be evaluated using a digital force gauge, and occlusal force distribution by using a t-scan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 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

Study Start

First participant enrolled

September 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

September 5, 2024

Last Update Submit

March 5, 2025

Conditions

Keywords

CAD-CAMComplete DenturesCopying , Denture

Outcome Measures

Primary Outcomes (1)

  • Assessment of Retention of maxillary complete denture

    The retention of a maxillary complete denture will be assessed using a digital force gauge meter, with retention measurements recorded in Newtons.

    at the time of denture insertion

Secondary Outcomes (1)

  • Evaluation of occlusal force distribution between right and left side

    at the time of denture insertion

Study Arms (3)

conventional heat-cured duplication technique.

ACTIVE COMPARATOR

Duplication of refitted complete removable dentures by conventional heat-cured technique from heat-cured polymethyl methacrylate resin.

Device: Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate.

3d Printed CAD/CAM duplication technique from Pink polymethyl methacrylate base resin

EXPERIMENTAL

Duplication of a refitted complete removable denture will be produced using a 3D-printed CAD/CAM technique where the denture base will be printed separately using pink base polymethyl methacrylate resin, and the teeth will be printed as one unit using tooth-colored resin, followed by assembling the two components.

Device: Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin.

3d Printed CAD/CAM duplication technique from white polymethyl methacrylate base resin

EXPERIMENTAL

Duplication of a refitted complete removable denture will be produced using a 3D-printed CAD/CAM technique where the denture will be printed as a single unit using tooth-colored resin, and the denture flange will be veneered with pink resin.

Device: Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin.

Interventions

The duplication of a refitted complete removable denture will be performed using conventional heat-cured polymethyl methacrylate through the conventional heat-cured polymerization technique.

conventional heat-cured duplication technique.

The duplication of a refitted complete removable denture will be performed using a 3D-printed CAD/CAM technique, where the denture base is printed separately with pink polymethyl methacrylate resin, and the teeth are printed as a single unit using tooth-colored resin, followed by the assembly of the two components.

3d Printed CAD/CAM duplication technique from Pink polymethyl methacrylate base resin

The duplication of a refitted complete removable denture will be performed using a 3D-printed CAD/CAM technique, where the denture base is printed as a single unit using tooth-colored resin, and the denture flange will be veneered with pink polymethyl methacrylate resin.

3d Printed CAD/CAM duplication technique from white polymethyl methacrylate base resin

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with old complete dentures without lost vertical dimension.
  • Patients with correct centric occluding relation.
  • The dentures should be esthetically and functionally satisfactory and exhibit reasonable retention and stability

You may not qualify if:

  • The presence of ridge or soft tissue pathology.
  • Diminished saliva production.
  • A history of medications affecting saliva quantity or quality.
  • Patients with temporomandibular joint problems.
  • The presence of sever ridge undercut.
  • Debilitated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 12345, Egypt

Location

Study Officials

  • Amany M Saad Farahat, PHD

    Ain Shams Univeristy

    PRINCIPAL INVESTIGATOR
  • Yasmine S Elsherbeeny, PHD

    Ain Shams Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Oral and Maxillofacial Prosthodontics

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

September 1, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations