Digital Evaluation of Accuracy for Removable Partial Denture Frameworks

Intra-oral Digital Evaluation of Fit Accuracy for Removable Partial Denture Frameworks Fabricated by Selective Laser Melting Using 2 Different Impression Techniques. A Cross-over Study.

Purpose: To compare the overall accuracy and fit of different components for mandibular metallic removable partial denture (RPD) frameworks fabricated by selective laser melting using combined analog-digital, and fully digital impression techniques.

Material and methods. Two RPD frameworks were fabricated for each of the 18 participants using each of the 2 techniques of the 18 participants enrolled, were of mandibular Kennedy class I, the first technique was the combined analog-digital workflow had the analog steps include: a physical impression was made using polyvinyl siloxane, stone casts were made, then the stone cast was scanned with a laboratory scanner to generate a digital cast. The 3Shape CAD software was then used to design a digital RPD, which was fabricated from a cobalt-chroumum alloy by selective laser melting. The second technique was fully digital where an intraoral digital scanner was used to make a definitive scan, which was sent to the 3Shape software for digitally designing the RPD framework and subsequent selective laser melting for fabrication. For both frameworks in the same participant, the same design was used for consistency. To assess the accuracy of fit, based on STL data analysis (intra-oral digital superimposition evaluation), a color map was constructed using non metrology software, and overall fit accuracy and the misfit (distance between each framework component and the reference intra-oral scan) were measured at rest, guiding plane and lingual plate areas.

Study Overview

• Status: Completed
• Conditions: Denture; Partial
• Intervention / Treatment: Other: Selective laser melting framework was fabricated using completely digital workflow

Detailed Description

Eighteen mandibular bilateral partially edentulous participants aged from 50 to 65 years having mandibular Class I Kennedy classification were selected randomly from the outpatient clinic of the prosthodontic department. The clinical study was explained to the patients and they accept it and an informed consent were signed by all them

For each patient, two different cobalt chromium removable partial denture frameworks were constructed; the first one was fabricated using combined analog-digital workflow (group 1) and the other framework was fabricated using completely digital workflow (group 2) and comparing them through evaluation of:

1. Over all accuracy
2. Accuracy of fit of occlusal rests and major connector and Guiding plane/plate relation.

Two techniques were used to fabricate 18 RPD frameworks in total. Fabrication of cobalt chromium removable partial denture framework using combined analog-digital workflow (group 1)

The Removable partial denture frameworks for group 1 were fabricated as follow:

The first technique was a combined analog-digital technique, in which a physical definitive impression was made and a stone cast was fabricated. a physical impression was made using polyvinyl siloxane impression material. , and a stone cast was poured using Type IV stone . In an edentulous area, border molding was first accomplished using a green modeling plastic impression compound . The impression and stone cast were evaluated critically to ensure quality. The stone cast was then scanned using a laboratory scanner to produce a virtual 3D master model. The 3Shape CAD software was used to design a digital RPD . The RPD framework was designed with an lingual plate mandibular major connector, RPI retentive clasps on the first premolars.

The definitive STL design file was then sent to the Dental Laboratory, to be selective laser melted in Co-Cr alloy

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr El Sheikh
    • Kafr Elsheikh, Kafr El Sheikh, Egypt, 6850001
      • Nourhan Ragheb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• mandibular Class I Kennedy classification were selected randomly from the outpatient clinic of the prosthodontic department

Exclusion Criteria:

• other classes of removable partial denture maxillary partially edentulous patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: selective laser melting removable partial denture frameworks fabricated by conventional technique	Other: Selective laser melting framework was fabricated using completely digital workflow; completely digital work flow Conventional technique versus complete digital technique
Other: selective laser melting framework was fabricated using completely digital workflow	Other: Selective laser melting framework was fabricated using completely digital workflow; completely digital work flow Conventional technique versus complete digital technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-oral digital Evaluation of fit accuracy for removable partial denture frameworks	Intra-oral digital Accuracy of fit evaluation between frame works by using medit compare software to exclude the value of point difference in different area at occlusal rest major connector	immediately after insertion of removable partial denture frame work

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: accuracy; partial denture; intra oral; digital evaluation; selective laser melting
• Other Study ID Numbers: KFSIRB200-130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No