Retention of Complete Denture Using Rapid Prototyping

NCT ID: NCT03507179

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-04
• Study Completion Date: 2018-11-04

Brief Summary

Nineteen patients will be selected from the clinic following the inclusion and exclusion criteria. Each one of them will receive two dentures. The first denture will be a conventional complete denture while the second denture will be a complete denture made by Rapid prototyping method.

For both groups, a preliminary impression will be made & after pouring the primary impression, self-cured acrylic resin trial denture bases with a wax rim will be constructed on the primary casts for the upper & lower arches for a jaw relation record. A facebow record will be used to mount the upper cast, while the lower cast will be mounted using a centric relation record. Setting of artificial teeth will be performed, then the denture will be tried in patient's mouth. Functional impression will be taken during the try in stage which.

For the first denture, the functional impression will be poured in normal way to obtain the master cast. Then Processing will be done in normal way and the denture will be finished and polished and delivered to the patient.

But for the second denture construction CBCT scanning of the try in with the functional impression will be done to obtain STL file then denture base manufacturing will be done by 3D printing.

For group A and group B Retention will be measured for the upper denture immediately, with a wash out period one month between the two dentures.

Detailed Description

Heat processed denture base is the treatment of choice for most of edentulous patients and it is considered as the golden standard and the main comparator for the new techniques. But using Heat Cured Acrylic resin would require many laboratory steps which introduce several errors . Meanwhile, the introduction of rapid prototyping method with high accuracy which eliminates some of the laboratory steps was the reason for choosing it to compare it with the conventional method.

Conditions

Retention of 3D Printed Dentures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

conventional dentures

a complete denture made through conventional processing technique

Group Type: PLACEBO_COMPARATOR

conventional dentures

Intervention Type: OTHER

conventional dentures

3d printed dentures

a complete denture made through 3D printing

Group Type: ACTIVE_COMPARATOR

3d printed denture

Intervention Type: OTHER

construction of a 3d printed denture through a recent method instead of conventional processing

Interventions

3d printed denture

construction of a 3d printed denture through a recent method instead of conventional processing

Intervention Type: OTHER

conventional dentures

conventional dentures

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ranging from 40-70 years.

2. Cooperative patients.

3. male or female patients

Exclusion Criteria

1. Pathological changes of residual ridges.

2. Patients with any systemic diseases.

3. Patients with xerostomia.

4. Patients with flabby and flat ridges.

5. Patients with allergy to resins.

6. Patient with sever undercuts, or irregular bony exostosis. -

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

lina khalaf

teaching assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

lina ismail, masters

Role: CONTACT

lina.net@hotmail.com

01092468850

Other Identifiers

lina''s protocol

Identifier Type: -

Identifier Source: org_study_id