To Evaluate the Complete Mandibular Dentures Produced Via 3D Printing in Comparison to Those Constructed From Metal-reinforced Acrylic Resin Regarding Their Retention (retention)

July 15, 2025 updated by: Ayman Fathy Farouk El-Awadi, National Research Centre, Egypt

Comparative Study of Retention of Mandibular Denture Bases Three-dimensional (3D) Printing Technique and Metal-reinforced Acrylic Resin

in this study we will construct denture for patient by different way and material one of this denture constructed digitally and the other one constructed in conventional way with metal reinforced. then we will measure the retention of the dentures

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the complete denture is constructed for completely edentulous patient. the different technique of construction aim to increase retention of denture to prevent dislodgment during mastication

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11553
        • National Resaerch Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Class I maxillary-mandibular relationship
  • well-maintained oral mucosa
  • normal salivary flow

Exclusion Criteria:

  • smokers patient
  • patient had any abnormalities in hard or soft tissues
  • severe ridge undercut
  • patient received radiation therapy to the head and neck region

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: complete edentulous patient receive 3D printed denture
group 1: 10 patients: Complete dentures constructed from poly-methyl methacrylate resin were used to create the mandibular and maxillary 3D-printed dentures
Device: digital complete denture
different method of denture construction
Active Comparator: complete edentulous patient receive metal reinforced denture
group 2: 10 patients: complete denture constructed from metal reinforced acrylic denture
Device: metal reinforced complete denture
different method of denture construction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
retention measurement
Time Frame: immediatlly after denture construction
To assess retention, a digital force gauge (Digital Force Gauge EXTECH 475044) was employed. All of the mandibular dentures were modified to receive a custom-made metal framework consisting of three tubes connected by a hook at the determining geometric center of the denture, two tubes extend 2 cm above the occlusal plane from the retromolar pad region, and one was made at the midline region lingual and below the central incisors. The mandibular denture's polished surface was then joined to the specially constructed custom-made metal framework using self-curing acrylic resin
immediatlly after denture construction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Centre, Egypt

Investigators

  • Principal Investigator: Ayman F Elawady, Ass prof, National research center, cairo, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2022

Primary Completion (Actual)

January 7, 2024

Study Completion (Actual)

January 7, 2025

Study Registration Dates

First Submitted

July 1, 2025

First Submitted That Met QC Criteria

July 10, 2025

First Posted (Actual)

July 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8887082022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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