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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 22
- Primary Endpoint
- Grade of framework passive fit
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Junyu Shi
Associate researcher
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University