Edentulous JawNCT05972148
Precision of Complete-arch Digital Implant Impressions With Intraoral Scanning Versus Photogrammetry
A study testing Digital scanning and Photogrammetry in people with Edentulous Jaw, run by William Negreiros at 1 site in United States.
Trial summary
The goal of this cross-over clinical trial is to investigate the precision of digital implant impressions using an intraoral scanner and photogrammetry in obtaining complete-arch implant-supported scans. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Digital scanning and Photogrammetry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2019to 2 May 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Present with a completely edentulous arch with at least four implants
- Have bone-level implants
- Intended for restoration with a screw-retained abutment-level fixed implant-supported prosthesis.
Who cannot join
- Patients unable to tolerate the digital scans impressions
- Presented with implants other than bone-level platforms
- Not intended for restorations with screw-retained abutment-level fixed implant-supported prosthesis
- Not completely edentulous.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Dental Medicine
Boston, Massachusetts, 02115
About this study
Official title: The Accuracy of Intraoral Scanning and Photogrammetry on the Clinical Fit of Long-span Frameworks
The goal of this cross-over clinical trial is to investigate the precision of digital implant impressions using an intraoral scanner and photogrammetry in obtaining complete-arch implant-supported scans.
The main question[s] it aims to answer are:
Read more
- Is there a difference in precision between intraoral scans and photogrammetry in obtaining digital implant scans?
- Will arch perimeter and jaw type (maxilla vs. mandible) affect the precision results?
Procedures: At each appointment, participants existing permanent/temporary prosthesis or healing caps were unscrewed and temporarily removed for the period of the consultation appointment.
Scanbodies were screwed into their implants for the duration of the appointment.
They underwent two types of digital implant impression procedures (five times each), including intraoral scan and photogrammetry.
Intraoral and extraoral photography were taken.
At the end of each appointment, the scanbodies were removed, and existing bridge/healing caps were reinserted.
The procedures were not painful or required any form of local anesthetic
Comparison group: Researchers compared the precision of intraoral scanning vs. photogrammetry to see which device provided the best precision outcomes.
- Conditions
- Edentulous Jaw
- Being tested
- Digital scanning, Photogrammetry
- Keywords
- edentulous/edentulism, CAD-CAM, implantology, prosthetic dentistry, clinical studies/trial, clinical outcomes
- Medical subject headings
- Jaw, Edentulous, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital scanningOther
Five intraoral scans, one for each arch before the insertion of scanbodies, were obtained. The implant locations were then marked, and the software trimmed a 6mm diameter circular section of the scan from the implant locations to allow the scanbodies to be added. Abutment-level polyetheretherketone (PEEK) scanbodies were hand-tightened onto each implant and not moved for the remainder of the scans. Scanbodies were scanned using a circular scan path, and scanning was finalized.
PhotogrammetryOther
Rectangular-shaped titanium photogrammetry scanbodies were hand-tightened onto the Implants. Scanbodies were not moved before completing all scans for each arch. A total of five scans of each arch were obtained using a photogrammetry device. Measurements were successfully recorded by turning them green on the computer screen.
| Study group | Role | What they receive |
|---|---|---|
| Intraoral Scanning | Active comparator | Not described Receives: Other: Digital scanning |
| Photogrammetry Scanning | Experimental | Not described Receives: Other: Photogrammetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the precision of intraoral scanner compared with photogrammetry in performing complete-arch digital implant impressions
Measured: During procedure [two hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start12 Aug 2019
- Primary completion20 Sep 2020
- Study completion2 May 2022
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.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Negreiros
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Sponsor-investigator, William Negreiros, Harvard School of Dental Medicine
- Investigators
- German O Gallucci, DMD, Study chair, Harvard School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972148
- Sponsor's protocol ID
- IRB18-0660
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans for IPD sharing because the study is complete.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Intraoral Scanning and Photogrammetry on the Clinical Fit of Long-span Frameworks
- ClinicalTrials.gov ID
- NCT05972148
- Acronym / sponsor ID
- IRB18-0660
- Conditions
- Edentulous Jaw
- Keywords
- edentulous/edentulism, CAD-CAM, implantology, prosthetic dentistry, clinical studies/trial, clinical outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- William NegreirosUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 2 Aug 2023 (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 cross-over clinical trial is to investigate the precision of digital implant impressions using an intraoral scanner and photogrammetry in obtaining complete-arch implant-supported scans.
The main question[s] it aims to answer are:
- Is there a difference in precision between intraoral scans and photogrammetry in obtaining digital implant scans?
- Will arch perimeter and jaw type (maxilla vs. mandible) affect the precision results?
Procedures: At each appointment, participants existing permanent/temporary prosthesis or healing caps were unscrewed and temporarily removed for the period of the consultation appointment.
Scanbodies were screwed into their implants for the duration of the appointment.
They underwent two types of digital implant impression procedures (five times each), including intraoral scan and photogrammetry.
Intraoral and extraoral photography were taken.
At the end of each appointment, the scanbodies were removed, and existing bridge/healing caps were reinserted.
The procedures were not painful or required any form of local anesthetic
Comparison group: Researchers compared the precision of intraoral scanning vs. photogrammetry to see which device provided the best precision outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoral Scanning | Active comparator | Other: Digital scanning |
| Photogrammetry Scanning | Experimental | Other: Photogrammetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Present with a completely edentulous arch with at least four implants
- Have bone-level implants
- Intended for restoration with a screw-retained abutment-level fixed implant-supported prosthesis.
Key exclusion criteria (4 listed)
- Patients unable to tolerate the digital scans impressions
- Presented with implants other than bone-level platforms
- Not intended for restorations with screw-retained abutment-level fixed implant-supported prosthesis
- Not completely edentulous.
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 scanningFive intraoral scans, one for each arch before the insertion of scanbodies, were obtained. The implant locations were then marked, and the software trimmed a 6mm diameter circular section of the scan from the implant locations to allow the scanbodies to be added. Abutment-level polyetheretherketone (PEEK) scanbodies were hand-tightened onto each implant and not moved for the remainder of the scans. Scanbodies were scanned using a circular scan path, and scanning was finalized. | Other | Intraoral Scanning |
| PhotogrammetryRectangular-shaped titanium photogrammetry scanbodies were hand-tightened onto the Implants. Scanbodies were not moved before completing all scans for each arch. A total of five scans of each arch were obtained using a photogrammetry device. Measurements were successfully recorded by turning them green on the computer screen. | Other | Photogrammetry Scanning |
Primary outcome
To investigate the precision of intraoral scanner compared with photogrammetry in performing complete-arch digital implant impressions
Time frame: During procedure [two hours]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No. There are no plans for IPD sharing because the study is complete.
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.
German O Gallucci, DMD study chair
Harvard School of Dental Medicine
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 scanning and Photogrammetry in people with Edentulous Jaw, run by William Negreiros at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 3 Aug 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To investigate the precision of intraoral scanner compared with photogrammetry in performing complete-arch digital implant impressions (time frame: During procedure [two hours]). 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 3 Aug 2023.