Digital Evaluation of Accuracy for Removable Partial Denture Frameworks

NCT06412159 | Completed DMC

• 1 other identifier: KFSIRB200-130
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose:Within subject study aim 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 24 participants using each of the 2 techniques of the 24 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.

Conditions

Denture; Partial

Keywords

partial denture; intra oral; digital evaluation; accuracy; selective laser melting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

selective laser melting removable partial denture frameworks fabricated by conventional technique

OTHER

selective laser melting removable partial denture frameworks fabricated by conventional technique

Other: Selective laser melting framework was fabricated using completely digital workflow

selective laser melting framework was fabricated using completely digital workflow

OTHER

selective laser melting framework was fabricated using completely digital workflow

Other: Selective laser melting framework was fabricated using completely digital workflow

Interventions

Selective laser melting framework was fabricated using completely digital workflow OTHER

completely digital work flow Conventional technique versus complete digital technique

selective laser melting framework was fabricated using completely digital workflow; selective laser melting removable partial denture frameworks fabricated by conventional technique

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• other classes of removable partial denture maxillary partially edentulous patients

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Nourhan Ragheb

Kafr Elsheikh, Kafr el-Sheikh Governorate, 6850001, Egypt

Location

Related Publications (1)

• Elgamal M, Ibrahim AM, Fadl BT, Ragheb NA. Accuracy assessment of removable partial denture frameworks fabricated by selective laser melting using two different workflows: A cross-over clinical study. BMC Oral Health. 2025 May 28;25(1):824. doi: 10.1186/s12903-025-06214-9.

  PMID: 40437453 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 14, 2024
• Study Start: January 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: February 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

EG (1)