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

March 27, 2024 updated by: Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: digital impression
intraoral scan
Device: intraoral scan
intraoral scanning of the edentulous arch and scan body
Active Comparator: conventional impression
open tray
Device: open tray impression
conventional method of impression making with silicone rubber material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the deliver of the framework

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH9H-2024-T29-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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