Edentulous JawNCT05770011
Digital Versus Conventional Impression Technique in Mandibular Arch
A study testing intraoral scanner of nonsplinted scan bodies, impression material and intraoral scanner of splinted scan bodies in people with Edentulous Jaw, run by Ain Shams University at 1 site in Egypt.
Trial summary
Objectives: Passive fit of screw retained frameworks is essential to avoid biological and mechanical failures in addition to transmission of unfavourable stresses to the bone-implant interface. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- intraoral scanner of nonsplinted scan bodies, impression material and intraoral scanner of splinted scan bodies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 May 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Patients' age range from 50 to 65 years old.
- Good oral hygiene is mandatory.
- Sufficient restorative space (15mm) to accept implant supported over denture diagnosed by mounting the diagnostic casts.
- Firm and healthy mucosa covering the alveolar ridge.
- Minimum bone width 5.5 mm buccolingually and of 12 mm bone height as diagnosed from the pre-operative cone beam computed tomography scan.
Who cannot join
- Heavy smokers.
- Patients with para functional habits.
- Tempromandibular Joint Disorders. (TMJ disorders)
- Patients with systemic disorders that may affect the results of this study.
- V-shaped dental arch.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Impression Techniques and Their Effect on the Passive Fit of Screw- Retained Bar Splinting Two Interforaminal Implants
Objectives: Passive fit of screw retained frameworks is essential to avoid biological and mechanical failures in addition to transmission of unfavourable stresses to the bone-implant interface. However, Several factors contribute to the passive fit of screw retained prosthesis such as relative parallelism between the implants, implant number, impression material, impression technique and method of prothesis fabrication. The current study aims to evaluate the accuracy of three different impression techniques on the fit of screw retained bar splinting two inter-foraminal implants.
Methods: The study presents evaluation of the passive fit of screw retained bar fabricated with three different impression techniques.
Read the detailed description
Surgical guide will be designed for completely edentulous patients. It will be inserted into the patient's mouth, stabilized against the upper denture and secured in place. dental implants will then be placed.
For bar fabrication using the first impression technique, closed-top primary impressions will be made followed by open top secondary impression. Extraoral scanning of the impression will be done followed by digital fabrication of the bar.
For bar fabrication using the second impression technique, scanning of the lower arch will be done using Omnicam intraoral scanner. Scanning will be done by a single calibrated operator who is trained on intraoral scanning techniques.
Scan bodies will be then screwed to the implants and scanning will be done. Both scans will be previewed on the computer desktop and superimposed together. A Standard tessellation language file will be then exported, downloaded and previewed in Inlab Exocad software .Implant system and the bar design will be selected from the software library. Then, the Standard tessellation Language file will be exported to the milling machine and milling of Cobalt chromium bar will be done.
For bar fabrication using the third technique, splinting of scan bodies will be done followed by intraoral scanning of the lower arch.
- Conditions
- Edentulous Jaw
- Being tested
- intraoral scanner of nonsplinted scan bodies, impression material, intraoral scanner of splinted scan bodies
- 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 scanner of nonsplinted scan bodiesDevice
scanning of non splinted scan bodies
impression materialDevice
conventional recording
intraoral scanner of splinted scan bodiesDevice
scanning of splinted scan bodies
| Study group | Role | What they receive |
|---|---|---|
| Conventional impression | Active comparator | Impression will be taken conventionally using rubber base open tray Receives: Device: impression material |
| digital impression without splinting the scan bodies | Experimental | Impression will be taken by intraoral scaner Receives: Device: intraoral scanner of nonsplinted scan bodies |
| digital impression with splinting the scan bodies | Experimental | Impression will be taken by intraoral scaner Receives: Device: intraoral scanner of splinted scan bodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
linear accuracy of impressions by superimposition
accurate details recorded by superimposition of the impressions using geomagic software program by measuring linear deviation in millimeters
Measured: 1 year
Angular accuracy of impressions by superimposition
accurate details recorded by superimposition of the impressions using geomagic software program by measuring angular displacements in degrees
Measured: 1 year
passive fit of screw retained bars
frame work fitting passively using screw resistance test using screw resistance parameter calculated by subtraction of passive and non passive situations angles of rotation in degrees
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Feb 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 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.
- 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
- Model description
- one control group and two comparator groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant Sherif Gamal eldin, Ain Shams University
- Investigators
- Marwa El Kassaby, PhD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770011
- Sponsor's protocol ID
- 2351992
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Impression Techniques and Their Effect on the Passive Fit of Screw- Retained Bar Splinting Two Interforaminal Implants
- ClinicalTrials.gov ID
- NCT05770011
- Acronym / sponsor ID
- 2351992
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 15 Mar 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.
Objectives: Passive fit of screw retained frameworks is essential to avoid biological and mechanical failures in addition to transmission of unfavourable stresses to the bone-implant interface. However, Several factors contribute to the passive fit of screw retained prosthesis such as relative parallelism between the implants, implant number, impression material, impression technique and method of prothesis fabrication. The current study aims to evaluate the accuracy of three different impression techniques on the fit of screw retained bar splinting two inter-foraminal implants.
Methods: The study presents evaluation of the passive fit of screw retained bar fabricated with three different impression techniques.
Detailed description
Surgical guide will be designed for completely edentulous patients. It will be inserted into the patient's mouth, stabilized against the upper denture and secured in place. dental implants will then be placed.
For bar fabrication using the first impression technique, closed-top primary impressions will be made followed by open top secondary impression. Extraoral scanning of the impression will be done followed by digital fabrication of the bar.
For bar fabrication using the second impression technique, scanning of the lower arch will be done using Omnicam intraoral scanner. Scanning will be done by a single calibrated operator who is trained on intraoral scanning techniques.
Scan bodies will be then screwed to the implants and scanning will be done. Both scans will be previewed on the computer desktop and superimposed together. A Standard tessellation language file will be then exported, downloaded and previewed in Inlab Exocad software .Implant system and the bar design will be selected from the software library. Then, the Standard tessellation Language file will be exported to the milling machine and milling of Cobalt chromium bar will be done.
For bar fabrication using the third technique, splinting of scan bodies will be done followed by intraoral scanning of the lower arch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- one control group and two comparator groups
| Arm | Type | Receives |
|---|---|---|
| Conventional impression | Active comparator | Device: impression materialImpression will be taken conventionally using rubber base open tray |
| digital impression without splinting the scan bodies | Experimental | Device: intraoral scanner of nonsplinted scan bodiesImpression will be taken by intraoral scaner |
| digital impression with splinting the scan bodies | Experimental | Device: intraoral scanner of splinted scan bodiesImpression will be taken by intraoral scaner |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Patients' age range from 50 to 65 years old.
- Good oral hygiene is mandatory.
- Sufficient restorative space (15mm) to accept implant supported over denture diagnosed by mounting the diagnostic casts.
- Firm and healthy mucosa covering the alveolar ridge.
- Minimum bone width 5.5 mm buccolingually and of 12 mm bone height as diagnosed from the pre-operative cone beam computed tomography scan.
Key exclusion criteria (5 listed)
- Heavy smokers.
- Patients with para functional habits.
- Tempromandibular Joint Disorders. (TMJ disorders)
- Patients with systemic disorders that may affect the results of this study.
- V-shaped dental arch.
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 scanner of nonsplinted scan bodiesscanning of non splinted scan bodies | Device | digital impression without splinting the scan bodies |
| impression materialconventional recording | Device | Conventional impression |
| intraoral scanner of splinted scan bodiesscanning of splinted scan bodies | Device | digital impression with splinting the scan bodies |
Primary outcome
linear accuracy of impressions by superimposition
Time frame: 1 year
accurate details recorded by superimposition of the impressions using geomagic software program by measuring linear deviation in millimeters
Angular accuracy of impressions by superimposition
Time frame: 1 year
accurate details recorded by superimposition of the impressions using geomagic software program by measuring angular displacements in degrees
passive fit of screw retained bars
Time frame: one year
frame work fitting passively using screw resistance test using screw resistance parameter calculated by subtraction of passive and non passive situations angles of rotation in degrees
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Edentulous Jaw
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
Active, not recruiting
A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
Jaw, Edentulous, Partially
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.
Marwa El Kassaby, PhD study director
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 intraoral scanner of nonsplinted scan bodies, impression material and intraoral scanner of splinted scan bodies in people with Edentulous Jaw, 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 5 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 28 Feb 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?
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?
linear accuracy of impressions by superimposition (time frame: 1 year). The study lists 3 primary outcomes in all. 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 28 Feb 2024.