Clinical trial NCT05955989: Relining Assessment of Digital and Conventional Fabricated Complete Denture Base
Official title: Relining Assessment of Digital and Conventional Fabricated Complete Denture Base
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Problem With Dentures
Keywords: Relining
Milled denture
3D-print
complete dentures
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
Collaborators: name: National Research Centre, Egypt
First posted: 2023-07-21
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of change in retentive force of the complete denture
timeFrame: on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion
measure: Assessment of change in occlusal forces during the follow up period.
timeFrame: on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: on day one of denture insertion and on the 9th month of denture insertion ( end of the follow up period)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
state: Dokki
Study officials:
affiliation: National Research Centre, Egypt
name: Asmaa N. Elboraey, Asso, Prof
role: PRINCIPAL_INVESTIGATOR
References: