Occlusal Relationship Assesment of Monolithic Zirconia FDPs

NCT04855084 | Completed

• 1 other identifier: KA-180043
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

To analyze in vivo occlusal accuracy and occlusal adjustment requirement, a cross-over clinical trial was designed. Two 3-unit tooth-supported posterior FDPs were planned to be made for each patient's single missing tooth gap, one with complete analog workflow (control group) and the other complete digital workflow (test group). The analog workflow aims for a porcelain fused to metal (PFM) FDP whereas the digital workflow aims for 3-unit monolithic Zr FDP. PFor half of the restorations, digital impression was planned to be taken first and to be followed by analog impression. As for the occlusal adjustment, in half of the study sites monolithic Zr FDPs were planned to be tried-in first, followed by metal-ceramic FDP and vice versa. One investigator (DK) was assigned to prepare the restoration sites and deliver the FDPs. All monolithic Zr and all metal-ceramic FDPs were designed and fabricated by the same experienced dental technician. One investigator (HL), that was not involved in the treatment intervention was assigned to make the 3D analysis of the volumetric occlusal adjustment amount.

Conditions

Tooth-loss

Keywords

Occlusal Relationship; Complete Digital Work-flow; Fixed Partial Denture; Fixed Dental Prosthesis

Outcome Measures

Primary Outcomes (1)

• The evaluation of effectiveness of workflows by assesing the occlusal registration accuracy of 3-unit FDPs that were fabricated with two different work-flows

  The occlusal registration accuracy and effectiveness of both analog and digital workflows by means of comparing quantitatively the occlusal adjustment requirement of 3-unit tooth supported metal-ceramic and Zr FDPs produced by analog work-flow use of semi-adjustable articulators with face-bow transfer and complete digital workflow, respectively

  At the baseline, the same day of delivery

Secondary Outcomes (1)

• Operator and Patient reported outcomes

  Impression visit and baseline visit (restoration delivery)

Study Arms (2)

Complete Digital Fixed Dental Prosthesis

EXPERIMENTAL

Following the Digital Impression using 3 Shape Trios Intraoral scanner, digital design, and manufacturing of the Monolithic Zirconia FDPs. Monolithic FDPs: before adjustment Using Intraoral Scanner, occlusal relationship assessment of the Monolithic FDPs before the occlusal adjustment. Monolithic FDPs: after adjustment Using Intraoral Scanner, occlusal relationship assessment of the Monolithic FDPs after the occlusal adjustment.

Other: Monolithic FDPs: before adjustment; Other: Monolithic FDPs: after adjustment; Other: Metal fused porcelain FDPs: before adjustment; Other: Metal fused porcelain FDPs: after adjustment

Analog Fixed Dental Prosthesis

ACTIVE COMPARATOR

Following the Conventional Impression, transfer to the articulator with Face bow. Manufacturing of the FDPs with lost wax technique and veneering. Metal fused porcelain FDPs: before adjustment Using Intraoral Scanner, occlusal relationship assessment of the metal fused to porcelain FDPs before the occlusal adjustment. Metal fused porcelain FDPs: after adjustment Using Intraoral Scanner, occlusal relationship assessment of the metal fused to porcelain FDPs after the occlusal adjustment.

Other: Monolithic FDPs: before adjustment; Other: Monolithic FDPs: after adjustment; Other: Metal fused porcelain FDPs: before adjustment; Other: Metal fused porcelain FDPs: after adjustment

Interventions

Monolithic FDPs: before adjustment OTHER

Before the occlusal adjustment, Occlusal relationship recording of the 3-unit monolithic FDPs which was fabricated following the complete digital work-flow.

Analog Fixed Dental Prosthesis; Complete Digital Fixed Dental Prosthesis

Monolithic FDPs: after adjustment OTHER

After the occlusal adjustment, Occlusal relationship recording of the 3-unit monolithic FDPs which was fabricated following the complete digital work-flow.

Analog Fixed Dental Prosthesis; Complete Digital Fixed Dental Prosthesis

Metal fused porcelain FDPs: before adjustment OTHER

Before the occlusal adjustment, Occlusal relationship recording of the 3-unit metal fused porcelain FDPs which was fabricated following the complete conventional manufacturing procedure.

Analog Fixed Dental Prosthesis; Complete Digital Fixed Dental Prosthesis

Metal fused porcelain FDPs: after adjustment OTHER

After the occlusal adjustment, digital occlusal relationship recording was done of the 3-unit metal fused porcelain FDPs which was fabricated following the complete conventional manufacturing procedure.

Analog Fixed Dental Prosthesis; Complete Digital Fixed Dental Prosthesis

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The individuals with the mandibular or maxillary single missing occlusal unit (2nd premolar, 1st molar) adjacent to a premolar and/or molar tooth
• Participants over 20 years old with no contradiction of dental treatment.
• Good oral hygiene habits, healthy periodontal status, no sign of bruxism (e.g. attrition score \>2 according to Wigdorowicz-Makowerowa, and/or muscle pain), and no self-reported grinding and/or clenching.
• No visible periapical lesion
• Presence of minimum 1:1 crown/root ratio
• Class I mobility (Nyman \& Lindhe 2003)
• No probing depth more than 4mm
• Presence of natural opposing teeth with no restorative treatment.
• Presence of a stable maximum intercuspation (MI) relationship

Sponsors & Collaborators

• Duygu Karasan: lead
• Hacettepe University: collaborator

Study Sites (1)

Hacettepe University Faculty of Dentistry

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Duygu Karasan, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Asistant, DDS, PhD

Model Details: A non-randomized one-control group study

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 22, 2021
• Study Start: May 24, 2018
• Primary Completion: August 7, 2018
• Study Completion: August 27, 2018
• Last Updated: April 22, 2021

Record last verified: 2021-04

Locations

TU (1)