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Relining Assessment of Digital and Conventional Fabricated Complete Denture Base

Relining Assessment of Digital and Conventional Fabricated Complete Denture Base

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05955989
Enrollment
12
Registered
2023-07-21
Start date
2023-05-01
Completion date
2026-01-01
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Problem With Dentures

Keywords

Relining, Milled denture, 3D-print, complete dentures

Brief summary

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.

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.

Interventions

OTHERsoft lining of complete denture processed by 3 different techniques.

soft lining for complete denture

Sponsors

Asmaa Nabil Elboraey
Lead SponsorOTHER
National Research Centre, Egypt
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

the patient is not know the type of prosthesis he will receive

Intervention model description

Three groups of completely edentulous patients. Each group will receive complete denture processed with different technique. After one year the patients will recalled and relining of the denture were made to gain the retention. After one year assessment of retention by digital force gauge, occlusion equilibrium by T-Scan and patient satisfaction (PS)

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of change in retentive force of the complete dentureon 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertionassessment of complete denture retention by digital force gauge
Assessment of change in occlusal forces during the follow up period.on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertionAssessment of occlusion equilibrium by Occlusense device

Secondary

MeasureTime frameDescription
Patient Satisfactionon 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.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORAsmaa N. Elboraey, Asso, Prof

National Research Centre, Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026