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Enrolling by invitationNCT07190820Updated Jun 10, 2026

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

An interventional study of digital impression and conventional impression in Edentulous Jaw, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Enrolling by invitation at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Edentulous Jaw

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Keywords

  • digital impression
  • implant restoration
03

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Other conditions deemed ineligible for inclusion by the investigator.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    digital impression

    Procedure: digital impression

  • Active comparator
    conventional impression

    Procedure: conventional impression

Interventions

  • Proceduredigital impression

    complete arch implant impression with intraoral photogrammetry

  • Procedureconventional impression

    conventional open tray splint impression

05

What researchers measure

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).

    Time frame: 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)

06

Study locations

1 site
  • Shanghai ninth people's hospital
    Shanghai, China
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 14, 2025

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT07190820
Lead sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Responsible party
Junyu Shi (associate professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University) — Principal investigator
First posted
Sep 24, 2025
Start date
Oct 30, 2025
Primary completion
Jul 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 10, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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