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

NCT06343441 | Not Yet Recruiting

• 1 other identifier: SH9H-2024-T29-2
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

digital impression

EXPERIMENTAL

intraoral scan

Device: intraoral scan

conventional impression

ACTIVE COMPARATOR

open tray

Device: open tray impression

Interventions

intraoral scan DEVICE

intraoral scanning of the edentulous arch and scan body

digital impression

open tray impression DEVICE

conventional method of impression making with silicone rubber material

conventional impression

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate researcher

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 2, 2024
• Study Start: March 31, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03