Edentulous JawNCT06509269
Intraoral Scanning v.s Desktop Scanning
A study testing intraoral scanning and Desktop scanning in people with Edentulous Jaw, run by British University In Egypt at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate the effect of intraoral scanning versus desktop scanning on the retention and adaptation of maxillary denture bases in completely edentulous patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- intraoral scanning and Desktop scanning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Oct 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with well-developed ridge
- Firm healthy mucosa
- Free from any signs of inflammation
Who cannot join
- Patients having flabby ridge
- Decreased flow of saliva
- Limited mouth opening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Intraoral Scanning Versus Desktop Scanning on The Retention Of Maxillary Denture Bases In Completely Edentulous Patients
The aim of this study was to evaluate the effect of intraoral scanning versus desktop scanning on the retention and adaptation of maxillary denture bases in completely edentulous patients.
Read the detailed description
The use of intra oral scanners (IOS) for rehabilitation of completely edentulous patients is still limited due to the difficulty in scanning large edentulous areas that are smooth and devoid of features. The stitching process can be defective, especially in the palatal area, where, the outmost deviations were reported in the palate when digitizing edentulous jaws with intraoral scanners. The main challenges for a fully digitized complete denture workflow are the digital impression of mobile tissues with functional border molding and the digital registration of the jaw relationship.
- Conditions
- Edentulous Jaw
- Being tested
- intraoral scanning, Desktop scanning
- Keywords
- Intraoral Scanning, CAD/CAM denture, Desktop Scanning
- 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 scanningProcedure or surgery
Intraoral Scanning of edentulous Jaw
Desktop scanningProcedure or surgery
Desktop scanning of definitive impression
| Study group | Role | What they receive |
|---|---|---|
| Desktop Scanning | Active comparator | Desktop scanning of Definitive Impression Receives: Procedure: Desktop scanning |
| IntraOral Scanning | Experimental | Intraoral scanning of edentulous Jaw Receives: Procedure: intraoral scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of denture base
Measuring tool: Digital force meter, Measuring unit: Newton (N)
Measured: "through study completion, an average of 1 year"
Adaptation of denture base
Measuring tool: Geomagic Control X software, Measuring Unit: Millimeter (mm)
Measured: "through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Oct 2020
- Primary completion1 Aug 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy khalifa ashmawy, British University In Egypt
- Investigators
- Ramy K Elashmawy, MSc, Principal investigator, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509269
- Sponsor's protocol ID
- Digital scanning
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osman RB, Alharbi NM. Influence of scan technology on the accuracy and speed of intraoral scanning systems for the edentulous maxilla: An in vitro study. J Prosthodont. 2023 Dec;32(9):821-828. doi: 10.1111/jopr.13633. Epub 2023 Jan 11.
PubMed 36571837Lo Russo L, Caradonna G, Troiano G, Salamini A, Guida L, Ciavarella D. Three-dimensional differences between intraoral scans and conventional impressions of edentulous jaws: A clinical study. J Prosthet Dent. 2020 Feb;123(2):264-268. doi: 10.1016/j.prosdent.2019.04.004. Epub 2019 May 29.
PubMed 31153614Manicone PF, De Angelis P, Rella E, Damis G, D'addona A. Patient preference and clinical working time between digital scanning and conventional impression making for implant-supported prostheses: A systematic review and meta-analysis. J Prosthet Dent. 2022 Oct;128(4):589-596. doi: 10.1016/j.prosdent.2020.11.042. Epub 2021 Mar 5.
PubMed 33678434
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Intraoral Scanning Versus Desktop Scanning on The Retention Of Maxillary Denture Bases In Completely Edentulous Patients
- ClinicalTrials.gov ID
- NCT06509269
- Acronym / sponsor ID
- Digital scanning
- Conditions
- Edentulous Jaw
- Keywords
- Intraoral Scanning, CAD/CAM denture, Desktop Scanning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 19 Jul 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.
The aim of this study was to evaluate the effect of intraoral scanning versus desktop scanning on the retention and adaptation of maxillary denture bases in completely edentulous patients.
Detailed description
The use of intra oral scanners (IOS) for rehabilitation of completely edentulous patients is still limited due to the difficulty in scanning large edentulous areas that are smooth and devoid of features. The stitching process can be defective, especially in the palatal area, where, the outmost deviations were reported in the palate when digitizing edentulous jaws with intraoral scanners. The main challenges for a fully digitized complete denture workflow are the digital impression of mobile tissues with functional border molding and the digital registration of the jaw relationship.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desktop Scanning | Active comparator | Procedure: Desktop scanningDesktop scanning of Definitive Impression |
| IntraOral Scanning | Experimental | Procedure: intraoral scanningIntraoral scanning of edentulous Jaw |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with well-developed ridge
- Firm healthy mucosa
- Free from any signs of inflammation
Key exclusion criteria (3 listed)
- Patients having flabby ridge
- Decreased flow of saliva
- Limited mouth opening
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 scanningIntraoral Scanning of edentulous Jaw | Procedure or surgery | IntraOral Scanning |
| Desktop scanningDesktop scanning of definitive impression | Procedure or surgery | Desktop Scanning |
Primary outcome
Retention of denture base
Time frame: "through study completion, an average of 1 year"
Measuring tool: Digital force meter, Measuring unit: Newton (N)
Adaptation of denture base
Time frame: "through study completion, an average of 1 year"
Measuring tool: Geomagic Control X software, Measuring Unit: Millimeter (mm)
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 19 Jul 2024.
- Background: PubMed 36571837Osman RB, Alharbi NM. Influence of scan technology on the accuracy and speed of intraoral scanning systems for the edentulous maxilla: An in vitro study. J Prosthodont. 2023 Dec;32(9):821-828. doi: 10.1111/jopr.13633. Epub 2023 Jan 11.
- Background: PubMed 31153614Lo Russo L, Caradonna G, Troiano G, Salamini A, Guida L, Ciavarella D. Three-dimensional differences between intraoral scans and conventional impressions of edentulous jaws: A clinical study. J Prosthet Dent. 2020 Feb;123(2):264-268. doi: 10.1016/j.prosdent.2019.04.004. Epub 2019 May 29.
- Results publication: PubMed 33678434Manicone PF, De Angelis P, Rella E, Damis G, D'addona A. Patient preference and clinical working time between digital scanning and conventional impression making for implant-supported prostheses: A systematic review and meta-analysis. J Prosthet Dent. 2022 Oct;128(4):589-596. doi: 10.1016/j.prosdent.2020.11.042. Epub 2021 Mar 5.
- 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.
Ramy K Elashmawy, MSc principal investigator
British University In Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoral scanning and Desktop scanning in people with Edentulous Jaw, run by British University In Egypt 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 3 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 19 Jul 2024. 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?
Retention of denture base (time frame: "through study completion, an average of 1 year"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06509269, which also lists 3 linked publications.
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 19 Jul 2024.