Accuracy of Two Methods of Making Impressions for Complete-arch Implant Supported Fixed Prosthesis

NCT ID: NCT06343441

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-12-31

Brief Summary

To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis

Detailed Description

The Intraoral scan is digital optical scan method, that has advantages such as being more comfortable, easy to transfer, and full digital workflow. Conventional impression using silicon rubber and gained stable accuracy of impression. This study aims to compare the accuracy of two methods.

Conditions

Edentulous Jaw

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

digital impression

intraoral scan

Group Type: EXPERIMENTAL

intraoral scan

Intervention Type: DEVICE

intraoral scanning of the edentulous arch and scan body

conventional impression

open tray

Group Type: ACTIVE_COMPARATOR

open tray impression

Intervention Type: DEVICE

conventional method of impression making with silicone rubber material

Interventions

intraoral scan

intraoral scanning of the edentulous arch and scan body

Intervention Type: DEVICE

open tray impression

conventional method of impression making with silicone rubber material

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18-70 years old (including 18 and 70 years old);
• The patient's maxilla or mandible cannot be preserved due to missing teeth or remaining teeth proposed for implant-retained restoration;
• The patient's missing teeth area is available for placement of 4-6 implants;
• Completion of osseointegration of the patient's implants after implant surgery;
• The patient has at least 2 mm width of keratinized mucosa in the remaining alveolar ridge;
• The patient voluntarily participates in the trial and signs an informed consent form

Exclusion Criteria

• The patient has a severe gag reflex;
• The patient has an intermaxillary distance of less than 20 mm in the posterior region;
• The distance between the two implants is less than 10 mm;
• Implants fitted with composite abutments with the abutment screw holes penetrating at an angle greater than 60 degrees to the alveolar ridge;
• Other patients judged by the investigator to be unsuitable for inclusion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Junyu Shi

Associate researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SH9H-2024-T29-2

Identifier Type: -

Identifier Source: org_study_id