Edentulous JawNCT07190820
Comparison of Accuracy of Full-arch Implant Digital and Conventional Impressions.
A study testing digital impression and conventional impression in people with Edentulous Jaw, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- digital impression and conventional impression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Accuracy of Digital and Conventional Impression in Edentulous Arch
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
- Being tested
- digital impression, conventional impression
- Keywords
- digital impression, implant restoration
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital impressionProcedure or surgery
complete arch implant impression with intraoral photogrammetry
conventional impressionProcedure or surgery
conventional open tray splint impression
| Study group | Role | What they receive |
|---|---|---|
| digital impression | Experimental | Not described Receives: Procedure: digital impression |
| conventional impression | Active comparator | Not described Receives: Procedure: conventional impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start30 Oct 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190820
- Sponsor's protocol ID
- SH9H-2025-T290-1
- Status last verified
- Jun 2026
- First submitted
- 18 Aug 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Accuracy of Digital and Conventional Impression in Edentulous Arch
- ClinicalTrials.gov ID
- NCT07190820
- Acronym / sponsor ID
- SH9H-2025-T290-1
- Conditions
- Edentulous Jaw
- Keywords
- digital impression, implant restoration
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| digital impression | Experimental | Procedure: digital impression |
| conventional impression | Active comparator | Procedure: conventional impression |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital impressioncomplete arch implant impression with intraoral photogrammetry | Procedure or surgery | digital impression |
| conventional impressionconventional open tray splint impression | Procedure or surgery | conventional impression |
Primary outcome
Vision and tactile score for evaluating passive fit of metal framework
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)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital impression and conventional impression in people with Edentulous Jaw, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision and tactile score for evaluating passive fit of metal framework (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.