Relining Assessment of Digital and Conventional Fabricated Complete Denture Base

NCT ID: NCT05955989

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Problem With Dentures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

soft lining of complete denture processed by 3 different techniques.

Intervention Type OTHER

soft lining for complete denture

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.

Group Type ACTIVE_COMPARATOR

soft lining of complete denture processed by 3 different techniques.

Intervention Type OTHER

soft lining for complete denture

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.

Group Type ACTIVE_COMPARATOR

soft lining of complete denture processed by 3 different techniques.

Intervention Type OTHER

soft lining for complete denture

Interventions

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soft lining of complete denture processed by 3 different techniques.

soft lining for complete denture

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role collaborator

Asmaa Nabil Elboraey

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Nabil Elboraey

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Asmaa N. Elboraey, Asso, Prof

Role: PRINCIPAL_INVESTIGATOR

National Research Centre, Egypt

Locations

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National Research Centre

Cairo, Dokki, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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14860202023

Identifier Type: -

Identifier Source: org_study_id

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