Prosthesis DurabilityNCT05321589
Accuracy of Conventional and Digital Impression Techniques Used for Maxillary Hybrid Prosthesis
A study testing impression techniques for implant used for maxillary screw retained hybrid prosthesis in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
evaluation and comparison of the accuracy of conventional and digital impression for full arch screw retained prosthesis for edentulous maxilla. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- impression techniques for implant used for maxillary screw retained hybrid prosthesis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 20 Mar 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients were selected according to the following inclusion criteria:
- Completely edentulous maxillary and mandibular ridges
- Healthy ridge covered by normal oral mucosa and free from any ridge flabbiness.
- All of the patients were dissatisfied with the retention and stability of their maxillary conventional dentures and expressed a strong desire for a more stable prosthesis.
- Sufficient bone quantity and quality in the front and posterior maxillary regions, as determined by preoperative CBCT, to accommodate six implants with a diameter of at least 3.5 mm and a length of at least 10 mm.
- Enough restorative space (from the mucosa covering the crest of the maxillary residual ridge to the occlusal plane) to allow the fixed prosthesis to be constructed ,preliminary jaw relationship revealed this.
- It's been at least a year since the last extraction.
Who cannot join
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- Systemic diseases that may alter tissue response to implantation and affects osseointegration (radiation, diabetes, osteoporosis, bleeding disorders or hepatic patients)
- Long term immunosuppressive and corticosteroid drug therapy.
- Patient with abnormal habits as clenching and bruxism.
- Smoking patients.
- Patients with problems in TMJ.
- Neuromuscular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Digital and Conventional Impression Techniques for Maxillary Full Arch Screw Retained Hybrid Prosthesis
evaluation and comparison of the accuracy of conventional and digital impression for full arch screw retained prosthesis for edentulous maxilla.
Read the detailed description
Each patient received 6 implants in the maxillary ridge (widely distributed across the arch) in the following positions: central incisors, canines/first premolar teeth and first molar teeth aided by surgical stent. then each patient received 2 types of impression techniques Technique 1 :conventional impression conventional open tray impression technique with splinted transfers using vinylpolysiloxane and Technique2 : Digital impression taken using original scan bodies torqued to the implants .three dimensional accuracy of impression techniques was evaluated using linear measurements and 3D deviation between the two techniques was measured.
- Conditions
- Prosthesis Durability
- Being tested
- impression techniques for implant used for maxillary screw retained hybrid prosthesis
- Keywords
- digital impression, conventional impression
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impression techniques for implant used for maxillary screw retained hybrid prosthesisOther
Also called digital and conventional impression techniques
conventional splinted open tray impression technique was done for maxillary implants to fabricate screw retained hybrid prosthesis and digital intra oral impression was done for the same patients after screwing scan bodies to the implants intra orally.
evaluation of accuracy and 3D deviation between the two techniques was done
| Study group | Role | What they receive |
|---|---|---|
| technique 1: conventional splinted open tray impression | Other | a conventional open tray impression technique splinted with ligature wire and duralay resin was done with polyvinyl siloxane impression .
analogues were screwed to the impression copings and casts were poured. Receives: Other: impression techniques for implant used for maxillary screw retained hybrid prosthesis |
| technique 2: digital intraoral impression technique | Other | scan bodies were screwed to implants intraorally and digital scanner was used to record digital impression, scanning protocol started from occlusal ,buccal to palatal surfaces.
The resulting scans were then exported in the standard tessellation format (.STL) Receives: Other: impression techniques for implant used for maxillary screw retained hybrid prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of impression technique
deviation measurements digitally
Measured: immediately after the intervention/procedure
Secondary outcomes (1)
passivity of final restoration
Clinical measurement of prosthesis passivity using single screw test of Sheffield.
Measured: immediately after the intervention/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Mar 2021
- Primary completion20 Feb 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis DurabilityStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- the conventional open tray splinted impression technique and the digital intraoral impression technique were done for each patient
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilan Altonbary, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321589
- Sponsor's protocol ID
- A25100221
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2022
- Last updated
- 11 Apr 2022
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Digital and Conventional Impression Techniques for Maxillary Full Arch Screw Retained Hybrid Prosthesis
- ClinicalTrials.gov ID
- NCT05321589
- Acronym / sponsor ID
- A25100221
- Conditions
- Prosthesis Durability
- Keywords
- digital impression, conventional impression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 11 Apr 2022 (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.
evaluation and comparison of the accuracy of conventional and digital impression for full arch screw retained prosthesis for edentulous maxilla.
Detailed description
Each patient received 6 implants in the maxillary ridge (widely distributed across the arch) in the following positions: central incisors, canines/first premolar teeth and first molar teeth aided by surgical stent. then each patient received 2 types of impression techniques Technique 1 :conventional impression conventional open tray impression technique with splinted transfers using vinylpolysiloxane and Technique2 : Digital impression taken using original scan bodies torqued to the implants .three dimensional accuracy of impression techniques was evaluated using linear measurements and 3D deviation between the two techniques was measured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the conventional open tray splinted impression technique and the digital intraoral impression technique were done for each patient
| Arm | Type | Receives |
|---|---|---|
| technique 1: conventional splinted open tray impression | Other | Other: impression techniques for implant used for maxillary screw retained hybrid prosthesisa conventional open tray impression technique splinted with ligature wire and duralay resin was done with polyvinyl siloxane impression . analogues were screwed to the impression copings and casts were poured. |
| technique 2: digital intraoral impression technique | Other | Other: impression techniques for implant used for maxillary screw retained hybrid prosthesisscan bodies were screwed to implants intraorally and digital scanner was used to record digital impression, scanning protocol started from occlusal ,buccal to palatal surfaces. The resulting scans were then exported in the standard tessellation format (.STL) |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patients were selected according to the following inclusion criteria:
Key exclusion criteria (7 listed)
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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 |
|---|---|---|
| impression techniques for implant used for maxillary screw retained hybrid prosthesisAlso: digital and conventional impression techniquesconventional splinted open tray impression technique was done for maxillary implants to fabricate screw retained hybrid prosthesis and digital intra oral impression was done for the same patients after screwing scan bodies to the implants intra orally. evaluation of accuracy and 3D deviation between the two techniques was done | Other | technique 1: conventional splinted open tray impression, technique 2: digital intraoral impression technique |
Primary outcome
accuracy of impression technique
Time frame: immediately after the intervention/procedure
deviation measurements digitally
1 secondary outcome
passivity of final restoration
Time frame: immediately after the intervention/procedure
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 11 Apr 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing impression techniques for implant used for maxillary screw retained hybrid prosthesis in people with Prosthesis Durability, run by Mansoura 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 7 inclusion and 7 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 11 Apr 2022. 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?
accuracy of impression technique (time frame: immediately after the intervention/procedure). 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 11 Apr 2022.