Comparison of Full-arch Implant-supported Frameworks From an Intraoral Scanning or From a Conventional Impression

NCT03992300 | Completed

• 1 other identifier: REST-ECT-2017-03
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To determine if adjustment of full-arch zirconia frameworks processed on a model obtained with an intraoral scanner and an auxiliary device is not inferior to that of identical frameworks obtained from an elastomeric impression. Materials and methods: Eight consecutive patients ready for a full-arch rehabilitation on already osseointegrated implants were selected. Two sets of impressions were taken, one open tray with polyether and splinted impression copings and a second one with an intraoral scanner. A verification plaster jig was used for the elastomeric impression and a prefabricated auxiliary device was used to adjust the optical intraoral impressions. Two full-zirconia frameworks with the same design were processed and tested on the patient by two independent calibrated operators. Accuracy of both frameworks was measured by calibrated blinded operators, who determined tactile adjustment, Sheffield test, radiographic adjustment, and screwing torque. Overall perception of adjustment was used to determine the better framework to be delivered to the patient. Hº: Frameworks obtained from an impression taken with an intraoral scanner are not inferior in accuracy to those obtained from a conventional elastomeric impression

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

• Accuracy of the framework

  Overall perception of adjustment of the two frameworks

  one day

Secondary Outcomes (4)

• Perception of the passivity

  1 day

• Optical adjustment

  1 day

• Radiographic adjustment

  1 day

• Screwing torque

  1 day

Study Arms (2)

Intraoral scanning

EXPERIMENTAL

An intraoral scanning is taken. An auxiliary device is used to achieve better accuracy. A zirconia framework is produced

Device: Clinical adjustment

Conventional scanning

ACTIVE COMPARATOR

A conventional elastomeric impression is taken and a zirconia framework is produced

Device: Clinical adjustment

Interventions

Clinical adjustment DEVICE

Accuracy of the framework is checked in the patient mouth by tactile perception, screwing torque, Sheffield test and radiography.

Conventional scanning; Intraoral scanning

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ·Patients with four or more implants already osseo-integrated ready to rehabilitate with a full-arch implant-supported framework of 10 or more units. ·Upper or lower jaw.

You may not qualify if:

• Implants not suitable for multiunit abutments.
• More than six implants.
• Peri-implantitis present in any implant.
• Need of a removable prosthesis.
• Patients unable to understand the purpose of the study.
• Patients with a restorative space higher than 15 milimiters.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Clinica Universitaria d'Odontologia

Sant Cugat Del Vallés, Barcelona, 08195, Spain

Location

Related Publications (31)

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MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• MIGUEL ROIG CAYON, MD DDS PHD

  Unversitat Internacional de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The frameworks are marked with a triangle or a circle in the distal aspect of the distal right molar. The outcomes assessor does not now to which group corresponds each framework
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Department of Restorative Dentistry

Model Details: Two frameworks with the same design obtained from two different models (intraoral scanning and conventional impression) are processed and tested in every patient

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 20, 2019
• Study Start: May 28, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)