Edentulous JawNCT06343441
Accuracy of Two Methods of Making Impressions for Complete-arch Implant Supported Fixed Prosthesis
A study testing intraoral scan and open tray impression in people with Edentulous Jaw, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial summary
To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- intraoral scan and open tray impression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis
Read the 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.
- Conditions
- Edentulous Jaw
- Being tested
- intraoral scan, open tray impression
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoral scanDevice
intraoral scanning of the edentulous arch and scan body
open tray impressionDevice
conventional method of impression making with silicone rubber material
| Study group | Role | What they receive |
|---|---|---|
| digital impression | Experimental | intraoral scan Receives: Device: intraoral scan |
| conventional impression | Active comparator | open tray Receives: Device: open tray impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the deliver of the framework
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start31 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- 22 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
- NCT06343441
- Sponsor's protocol ID
- SH9H-2024-T29-2
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 2 Apr 2024
- 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 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06343441
- Acronym / sponsor ID
- SH9H-2024-T29-2
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 31 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Apr 2024 (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.
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
- 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 | Device: intraoral scanintraoral scan |
| conventional impression | Active comparator | Device: open tray impressionopen tray |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| intraoral scanintraoral scanning of the edentulous arch and scan body | Device | digital impression |
| open tray impressionconventional method of impression making with silicone rubber material | Device | conventional impression |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
Related trials for Edentulous Jaw
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing intraoral scan and open tray impression in people with Edentulous Jaw, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Grade of framework passive fit (time frame: during the deliver of the framework). 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 2 Apr 2024.