Prosthesis DurabilityNCT06050187
Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch
A study testing implant casts fabrication in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will be conducted to compare between accuracy of 3D printed implant cast produced from digital impression and conventional stone cast produced from conventional splinted open tray impression for edentulous mandibular arch with four implants. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- implant casts fabrication
- 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
- 21 Dec 2022to 17 Dec 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Patients were healthy and free from all systemic diseases that affect osseointegration or bone resorption around the implant as recorded from medical and dental history.
- Patients were free from all oral pathological conditions and any remaining roots which were verified by pre-operative panoramic radiograph.
- Patients with U shaped arch, flat mandibular alveolar ridge covered with even compressibility healthy mucosa and gingival thickness of about 2mm verified by dual scan of cone beam computed tomography (CBCT) during treatment planning. Fig.(1)
- Adequate residual alveolar bone quality D2 bone type in the anterior and premolar regions according to the Misch bone density classification scheme (850 to1250 housefield units) confirmed by CBCT.
- Angel's class I maxillomandibular relation with moderate inter- arch space (20 mm) confirmed through tentative jaw relationship, and restorative space of at least 15 mm determined by putty index technique
- Patients complain from poor retentive mandibular denture seeking for alternative fixed options.
- Patient who is motivated, agreed with the follow-up visits and willing to return for follow-up appointments.
Who cannot join
- • Patient with absolute contraindications that interfere with surgical placement and osseointegration of implants as uncontrolled diabetes mellitus, generalized osteoporosis, recent myocardial infarction, patient with radiotherapy.
- Patient with relative contraindication such as UN controlled diabetes mellitus, moderate smoking and alcoholism, patient with TMJ disorder and heavy smokers for more than10 cigarettes per day.
- Patient with local contra indication as insufficient bone quality, localized lesion in canine area and premolar area, unfavourable position of the lower alveolar or mental nerve, bone defects as verified by cone beam CT.
- Uncooperative patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch: A Comparative Study
This study will be conducted to compare between accuracy of 3D printed implant cast produced from digital impression and conventional stone cast produced from conventional splinted open tray impression for edentulous mandibular arch with four implants.
- Conditions
- Prosthesis Durability
- Being tested
- implant casts fabrication
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant casts fabricationProcedure or surgery
four implant casts fabricated
| Study group | Role | What they receive |
|---|---|---|
| Group I conventional stone cast | Active comparator | Mandibular stone cast with 4 parallel implants analogues in canines and second premolar regions will be fabricated conventionally. Receives: Procedure: implant casts fabrication |
| Group II 3D printed implant cast | Active comparator | 3D printed implant mandibular cast with 4 parallel digital implants analogues in canines and second premolar regions will be fabricated digitally. Receives: Procedure: implant casts fabrication |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of 3D printed casts
Accuracy of 3D printed casts will be evaluated digitally by geomagic software
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start21 Dec 2022
- Primary completion27 Dec 2023 (estimated)
- Study completion17 Dec 2024 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050187
- Sponsor's protocol ID
- A07030123
- Status last verified
- Sep 2023
- First submitted
- 17 Sep 2023
- Last updated
- 20 Dec 2023
- Results posted
- 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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch: A Comparative Study
- ClinicalTrials.gov ID
- NCT06050187
- Acronym / sponsor ID
- A07030123
- Conditions
- Prosthesis Durability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 27 Dec 2023 (estimated)
- Study completion
- 17 Dec 2024 (estimated)
- First posted
- 22 Sep 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.
This study will be conducted to compare between accuracy of 3D printed implant cast produced from digital impression and conventional stone cast produced from conventional splinted open tray impression for edentulous mandibular arch with four implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I conventional stone cast | Active comparator | Procedure: implant casts fabricationMandibular stone cast with 4 parallel implants analogues in canines and second premolar regions will be fabricated conventionally. |
| Group II 3D printed implant cast | Active comparator | Procedure: implant casts fabrication3D printed implant mandibular cast with 4 parallel digital implants analogues in canines and second premolar regions will be fabricated digitally. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Patients were healthy and free from all systemic diseases that affect osseointegration or bone resorption around the implant as recorded from medical and dental history.
Key exclusion criteria (4 listed)
- • Patient with absolute contraindications that interfere with surgical placement and osseointegration of implants as uncontrolled diabetes mellitus, generalized osteoporosis, recent myocardial infarction, patient with radiotherapy.
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 |
|---|---|---|
| implant casts fabricationfour implant casts fabricated | Procedure or surgery | Group I conventional stone cast, Group II 3D printed implant cast |
Primary outcome
accuracy of 3D printed casts
Time frame: 6 month
Accuracy of 3D printed casts will be evaluated digitally by geomagic software
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 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.
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 implant casts fabrication 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 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: status not confirmed, as of the sponsor's last update on 20 Dec 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?
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?
accuracy of 3D printed casts (time frame: 6 month). 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 20 Dec 2023.