Comparison of Accuracy of Full-arch Implant Digital and Conventional Impressions.

NCT07190820 | Enrolling By Invitation

• 1 other identifier: SH9H-2025-T290-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether the accuracy of digital impressions is comparable to conventional impressions. It will also learn about the clinical effect of different method. The main questions it aims to answer are: Does drug ABC lower the number of times participants need to use a rescue inhaler? What medical problems do participants have when taking drug ABC? Researchers will compare digital impression to conventional impression to see if the accuracy of the digital method. Participants will: Take an impression with one of the methods Visit the clinic a total of 6 times for checkups and tests

Conditions

Edentulous Jaw

Keywords

digital impression; implant restoration

Outcome Measures

Primary Outcomes (1)

• Vision and tactile score for evaluating passive fit of metal framework

  Five aspects are evaluated, each aspect is scored as 0 or1. The score ranges from 0 to 5 points. 1、Framework rocking upon seating？2、 Gap assessment with single screw test. The method utilized an explorer with an approximately Ø60-µm tip to evaluate the margins of the metal framework.3、 Gap assessment with all screws tightened. 4、Are the screws threading smoothly? 5、Radiographic assessment of framework fit (check for gaps).

  Periprocedural: At the time of the titanium framework try-in: the try-in of the framework to the patient is before final delivery. (The delivery of the final prosthesis is the baseline)

Study Arms (2)

digital impression

EXPERIMENTAL

Procedure: digital impression

conventional impression

ACTIVE COMPARATOR

Procedure: conventional impression

Interventions

conventional impression PROCEDURE

conventional open tray splint impression

conventional impression

digital impression PROCEDURE

complete arch implant impression with intraoral photogrammetry

digital impression

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 30-80 years (inclusive) with no gender restriction.
• Patients who will receive a full-arch one-piece implant-supported fixed
• permanent restoration in the maxilla or mandible.
• Patients with osseointegrated implants after surgery.
• Patients voluntarily participate in the trial and sign the informed consent form.

You may not qualify if:

• Patients with insufficient interarch space in the posterior region for impression coping placement.
• Patients with minimal inter-implant distance may prevent impression coping installation.
• Patients with temporomandibular joint (TMJ) disorders are unable to maintain prolonged mouth opening for impression procedures.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai ninth people's hospital

Shanghai, China

Location

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 professor

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 24, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CN (1)