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Completed

NCT Number: NCT05955989

Relining Assessment of Digital and Conventional Fabricated Complete Denture Base

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre

Cairo, Dokki, 12622, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

soft lining of complete denture processed by 3 different techniques.

Other

soft lining for complete denture

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Asmaa Nabil Elboraey

Other

Collaborators

  • National Research Centre, Egypt

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 21, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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