Digital TechnologyNCT05948254
Utilized Scan Body Technique For Triple Function
A study testing Triple function scan body in people with Digital Technology and Dental Implant, run by Ain Shams University at 1 site in Egypt.
Trial summary
A triple function scan Body were done on healed dental implant, thus simplifying the workflow for full arch cases and reducing the number of visits to only 3 visits. In this technique, scan bodies were utilized for implant position scanning, facial scan alignment and as stoppers for jaw relation capturing as scan… Read more about this study
- Who is it for?
- Ages 22 to 45 years
- Conditions the study is for
- Digital Technology, Dental Implant, Occlusion
- What is being tested?
- Triple function scan body
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 11 May 2022to 31 May 2023
- 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 22 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patient had at least one edentulous arch with at least 5 osseointegrated implants with healing period of 3 months after surgical procedure.
- Implants are stable
- Systemically free
Who cannot join
- Smokers
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilized Scan Body Technique For Jaw Relation Registration And Face Scan Alignment (Triple Function Scan Body)
A triple function scan Body were done on healed dental implant, thus simplifying the workflow for full arch cases and reducing the number of visits to only 3 visits. In this technique, scan bodies were utilized for implant position scanning, facial scan alignment and as stoppers for jaw relation capturing as scan bodies were used as stoppers for jaw relation registration.
Read the detailed description
The present article describes a novel technique for merging a patient's facial scan with implant scan body and in the same time utilizing the same scan body for recording the jaw relation in only one visit. As a result, a facially driven full-arch implant-supported interim prosthesis can be fabricated first followed by the final restoration in a simplified approach. The aim of this study is to determine whether there is a difference between virtual design and reality using scan body technique (triple function scan body which reflects the accuracy of the scanning protocol. The null hypothesis established that there was consistency between the virtual design and prosthesis in patient's mouth. The scan body was placed in the edentulous arch in the jaw scan step so that bite registration would be easier for the intraoral scanner (IOS) in order to be able to capture both the teeth of the antagonist and part of the scan body in the edentulous jaw simultaneously.
- Conditions
- Digital Technology, Dental Implant, Occlusion
- Being tested
- Triple function scan body
- Keywords
- Jaw relation, Scan body, Full arch dental implants
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple function scan bodyProcedure or surgery
The scan bodies were used to scan the implant position, Jaw registration and facial scan alignment, First of all scan bodies were selected according to vertical dimension of occlusion, then the emergence profile together with the selected scan body were scanned,All scan bodies were then removed from the patient mouth except one or even two that were scanned in the jaw scan step, this scan body was utilized as a stopper, the patient was asked to bite until the scan body came in contact with the lower or upper teeth in case of edentulous upper or lower arch respectively, scan body in place (in the same orientation of the previous jaw scan ) provided that at least the tip of the scan body appeared when the patient is asked to smile which would be used as a common area so that the intra oral scanner can relate the jaw scan to the lips and face.
| Study group | Role | What they receive |
|---|---|---|
| Triple Function Scan Body | Other | Full arch implants were placed, a triple function scan Body and thus simplifying the workflow for full arch cases and reducing the number of visits to only 3 visits. Scan bodies were utilized for implant position scanning, facial scan alignment and as stoppers for jaw relation capturing as scan bodies were used as stoppers for jaw relation registration. Receives: Procedure: Triple function scan body |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of consistency in simultaneous contacts in maximal intercuspal position
At 2 months follow up after final prostheses delivery, a frontal photo was taken and an intra oral scan was made for each patient in order to assess the degree of consistency between initial virtual design and reality using Exocad Software, The intra oral Scan of the full arch restoration is inserted into Exocad Software and the interocclusal contacts for all teeth were detected, classifying them in a dichotomy variable (yes/no) contact or not per tooth.
Measured: 2 months following the final prosthesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start11 May 2022
- Primary completion24 Apr 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital TechnologyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Triple Function Scan Body
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor
- Investigators
- Doaa Adel-Khattab, PhD, Principal investigator, Associate Professor Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948254
- Sponsor's protocol ID
- 245862
- Status last verified
- May 2022
- First submitted
- 10 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilized Scan Body Technique For Jaw Relation Registration And Face Scan Alignment (Triple Function Scan Body)
- ClinicalTrials.gov ID
- NCT05948254
- Acronym / sponsor ID
- 245862
- Conditions
- Digital Technology, Dental Implant, Occlusion
- Keywords
- Jaw relation, Scan body, Full arch dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 11 May 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 17 Jul 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.
A triple function scan Body were done on healed dental implant, thus simplifying the workflow for full arch cases and reducing the number of visits to only 3 visits. In this technique, scan bodies were utilized for implant position scanning, facial scan alignment and as stoppers for jaw relation capturing as scan bodies were used as stoppers for jaw relation registration.
Detailed description
The present article describes a novel technique for merging a patient's facial scan with implant scan body and in the same time utilizing the same scan body for recording the jaw relation in only one visit. As a result, a facially driven full-arch implant-supported interim prosthesis can be fabricated first followed by the final restoration in a simplified approach. The aim of this study is to determine whether there is a difference between virtual design and reality using scan body technique (triple function scan body which reflects the accuracy of the scanning protocol. The null hypothesis established that there was consistency between the virtual design and prosthesis in patient's mouth. The scan body was placed in the edentulous arch in the jaw scan step so that bite registration would be easier for the intraoral scanner (IOS) in order to be able to capture both the teeth of the antagonist and part of the scan body in the edentulous jaw simultaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Triple Function Scan Body
| Arm | Type | Receives |
|---|---|---|
| Triple Function Scan Body | Other | Procedure: Triple function scan bodyFull arch implants were placed, a triple function scan Body and thus simplifying the workflow for full arch cases and reducing the number of visits to only 3 visits. Scan bodies were utilized for implant position scanning, facial scan alignment and as stoppers for jaw relation capturing as scan bodies were used as stoppers for jaw relation registration. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patient had at least one edentulous arch with at least 5 osseointegrated implants with healing period of 3 months after surgical procedure.
- Implants are stable
- Systemically free
Key exclusion criteria (2 listed)
- Smokers
- Uncooperative patients
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 |
|---|---|---|
| Triple function scan bodyThe scan bodies were used to scan the implant position, Jaw registration and facial scan alignment, First of all scan bodies were selected according to vertical dimension of occlusion, then the emergence profile together with the selected scan body were scanned,All scan bodies were then removed from the patient mouth except one or even two that were scanned in the jaw scan step, this scan body was utilized as a stopper, the patient was asked to bite until the scan body came in contact with the lower or upper teeth in case of edentulous upper or lower arch respectively, scan body in place (in the same orientation of the previous jaw scan ) provided that at least the tip of the scan body appeared when the patient is asked to smile which would be used as a common area so that the intra oral scanner can relate the jaw scan to the lips and face. | Procedure or surgery | Triple Function Scan Body |
Primary outcome
percentage of consistency in simultaneous contacts in maximal intercuspal position
Time frame: 2 months following the final prosthesis
At 2 months follow up after final prostheses delivery, a frontal photo was taken and an intra oral scan was made for each patient in order to assess the degree of consistency between initial virtual design and reality using Exocad Software, The intra oral Scan of the full arch restoration is inserted into Exocad Software and the interocclusal contacts for all teeth were detected, classifying them in a dichotomy variable (yes/no) contact or not per tooth.
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 17 Jul 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Doaa Adel-Khattab, PhD principal investigator
Associate Professor Faculty of Dentistry, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple function scan body in people with Digital Technology and Dental Implant, run by Ain Shams University at 1 site in Egypt.
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 2 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 17 Jul 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 Egypt. 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?
percentage of consistency in simultaneous contacts in maximal intercuspal position (time frame: 2 months following the final prosthesis). 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 17 Jul 2023.