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

Edentulous Jaw Clinical Trial

Official title:

A Randomized Controlled, Double-blind Clinical Trial to Evaluate the Clinical Effectiveness of Two Methods of Taking Impressions for an Implant-supported Fixed Prostheses With One-piece Titanium Frameworks in Edentulous Jaws

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06343441
• Other study ID #: SH9H-2024-T29-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous
• Mouth, Edentulous

Intervention

Device:
• intraoral scan
intraoral scanning of the edentulous arch and scan body
• open tray impression
conventional method of impression making with silicone rubber material

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade of framework passive fit	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.	during the deliver of the framework