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

Not Applicable

Not yet recruiting

• Conditions: Edentulous Jaw
• Interventions: Device: open tray impression; Device: intraoral scan

• Registration Number: NCT06343441
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-27
• Last Update Submitted: 2024-03-27
• Study Start: 2024-03-31
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional impression	open tray impression	open tray
digital impression	intraoral scan	intraoral scan

Primary Outcome Measures

Name	Time	Method
Grade of framework passive fit	during the deliver of the framework	The passive fit of the titanium framework is measured with a scoring system. Five aspects are evaluated. whether to pry; Single Screw Probing misfit; All Screws; Probing misfit; Smooth during screwing; X-ray for misfit. For each aspect, 0/1 is scored. the total score is between 0 and 5.