Relining Assessment of Digital and Conventional Fabricated Complete Denture Base

May 30, 2026 updated by: Asmaa Nabil Elboraey
The bond between the resilient denture liner material and the denture base is essential to improve complete denture accuracy and retention to the underlying ridge. The bonding characteristics between resilient denture reline materials and conventional Polymethyl methacrylate (PMMA) denture base polymers have been evaluated extensively. But with the introduction of digital fabricated complete denture, the bond characteristics between digitally fabricated dentures and denture liner is sparse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dental prostheses fabricated using different digital technology have become popular in recent years. Computer-aided design and computer-aided manufacturing (CAD-CAM) technology provides two techniques, milled or 3D printed technique which simplified the complex dental laboratory procedures by digitalizing the prosthetic design and automating the manufacturing process. Digitally fabricated prostheses have been reported to have excellent accuracy factor that has been related to favorable clinical performance. However, bone resorption underneath any mucosa supported prosthesis is not avoidable. Resilient liners are required for most complete dentures after 6 to 12 months to improve adaptation to the underlying tissues and to reduce the force transmitted to the edentulous ridge during functionThe bond between the resilient denture liner material and the denture base is essential to improve complete denture accuracy and retention to the underlying ridge. The bonding characteristics between resilient denture reline materials and conventional Polymethyl methacrylate (PMMA) denture base polymers have been evaluated extensively. But with the introduction of digital fabricated complete denture, the bond characteristics between digitally fabricated dentures and denture liner is sparse.

Therefore, the aim of this project is to evaluate the bond strength and effectiveness of denture reline of CAD/CAM (milled and 3D printed ) fabricated complete dentures compared to conventional heat-polymerized denture base.

Study Type

Interventional

Enrollment (Actual)

12

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
    • Dokki
      • Cairo, Dokki, Egypt, 12622
        • National Research Centre

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients are free from any systemic diseases that might affect neuro-muscular control.
  • Patients having class I maxilla-mandibular relationship
  • Patients having healthy mucosa and normal salivary flow

Exclusion Criteria:

  • Patients have severe bony undercut.
  • Uncooperative patients.
  • Patients having radiation to the head and neck region.
  • Smoker patients.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Complete denture fabricated from Conventional heat curing
The patients in this group will receive complete dentures fabricated by conventional heat curing method. and they will receive soft lining of the complete dentures after one year.
Other: soft lining of complete denture processed by 3 different techniques.
soft lining for complete denture
Active Comparator: complete denture fabricated by CAD/CAM milled technology
The patients in this group will receive complete dentures fabricated by CAD/CAM ( Computer aided design/ Computer aided manufacture) method. and they will receive soft lining of the complete dentures after one year.
Other: soft lining of complete denture processed by 3 different techniques.
soft lining for complete denture
Active Comparator: complete denture fabricated by CAD/CAM 3D Printed technology
The patients in this group will receive complete dentures fabricated by 3D printing ( three dimension) method. and they will receive soft lining of the complete dentures after one year.
Other: soft lining of complete denture processed by 3 different techniques.
soft lining for complete denture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of change in retentive force of the complete denture
Time Frame: on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion
assessment of complete denture retention by digital force gauge
on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion
Assessment of change in occlusal forces during the follow up period.
Time Frame: on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion
Assessment of occlusion equilibrium by Occlusense device
on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: on day one of denture insertion and on the 9th month of denture insertion ( end of the follow up period)
a questionnaire was designed containing 5 questions regarding the following parameters: retention, comfort, appearance, phonetics and pain. Increasing the score meaning more patient satisfaction.
on day one of denture insertion and on the 9th month of denture insertion ( end of the follow up period)

Collaborators and Investigators

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

Sponsor

Asmaa Nabil Elboraey

Collaborators

National Research Centre, Egypt

Investigators

  • Principal Investigator: Asmaa N. Elboraey, Asso, Prof, National Research Centre, 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)

May 1, 2023

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13060207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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