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Clinical Trials/NCT06343441
NCT06343441
Not yet recruiting
Not Applicable

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

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University0 sites22 target enrollmentMarch 31, 2024
ConditionsEdentulous Jaw

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Edentulous Jaw
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enrollment
22
Primary Endpoint
Grade of framework passive fit
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 31, 2024
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Responsible Party
Principal Investigator
Principal Investigator

Junyu Shi

Associate researcher

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

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

Outcomes

Primary Outcomes

Grade of framework passive fit

Time Frame: 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.

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