Prosthesis DurabilityNCT06031506
Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants
A study testing Implant supported hybrid maxillary prosthesis in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
This clinical study will aim to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental 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 supported hybrid maxillary prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 16 Jun 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
- All patients will have healthy healed residual alveolar ridges, Angle's class I maxillomandibular relations, available maxillary restorative space. This will be verified by tentative jaw relation records.
Who cannot join
- All detrimental bad habits like smoking, TMJ clicking or TMJ dysfunction will be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University ,Faculty of dentistry
Al Mansurah, P.O.Box:35516
About this study
Official title: Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants to Support Immediately Loaded Hybrid Prosthesis.One Year Evaluation of Occlusal Contact and Ridge Resorption
This clinical study will aim to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants
Read the detailed description
The aim of this study will be to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants and that of the atrophied maxilla rehabilitated with immediate loaded hyprid prosthesis supported by 4 zygomatic implants.
- Conditions
- Prosthesis Durability
- Being tested
- Implant supported hybrid maxillary prosthesis
- 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 supported hybrid maxillary prosthesisDevice
All patients will receive immediately loaded hybrid prosthesis supported by 4 zygomatic implants.
| Study group | Role | What they receive |
|---|---|---|
| quad zygomatic hybrid maxillary prosthesis | Experimental | All patients will be rehabilitated with immediate loaded hybrid prosthesis supported by 4 zygomatic implants. Receives: Device: Implant supported hybrid maxillary prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
The patient satisfaction will be evaluated using the visual analog scale (VAS) questionnaire at base line, 6, and 12 months later
Measured: one year
marginal implant bone loss
The implant marginal bone height changes will be measured radiographically at base line, 6, and 12 months later
Measured: one year
Secondary outcomes (1)
posterior area index
the area index of the anterior and posterior maxillary ridge will be measured radiographically at base line, 6, and 12 months later
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 posted11 Sep 2023
- Study start15 Dec 2022
- Primary completion7 Mar 2023
- Study completion16 Jun 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
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive conventional maxillary and mandibular complete dentures The implant size will be selected for each area according to the available bone length and width as measured by CBCT radiograph. All implants will be surgically installed guided by steriolethognathic stents \- Multi-unit abutments will be connected to implants and will be immedietly loaded by fixed full arch screw retained provisional acrylic restoration. Final prosthesis will be delivered 6-8 months later
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT06031506
- Sponsor's protocol ID
- M03071221
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 11 Sep 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 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants to Support Immediately Loaded Hybrid Prosthesis.One Year Evaluation of Occlusal Contact and Ridge Resorption
- ClinicalTrials.gov ID
- NCT06031506
- Acronym / sponsor ID
- M03071221
- Conditions
- Prosthesis Durability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 16 Jun 2024 (estimated)
- First posted
- 11 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 clinical study will aim to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants
Detailed description
The aim of this study will be to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants and that of the atrophied maxilla rehabilitated with immediate loaded hyprid prosthesis supported by 4 zygomatic implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive conventional maxillary and mandibular complete dentures The implant size will be selected for each area according to the available bone length and width as measured by CBCT radiograph. All implants will be surgically installed guided by steriolethognathic stents - Multi-unit abutments will be connected to implants and will be immedietly loaded by fixed full arch screw retained provisional acrylic restoration. Final prosthesis will be delivered 6-8 months later
| Arm | Type | Receives |
|---|---|---|
| quad zygomatic hybrid maxillary prosthesis | Experimental | Device: Implant supported hybrid maxillary prosthesisAll patients will be rehabilitated with immediate loaded hybrid prosthesis supported by 4 zygomatic implants. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients will have healthy healed residual alveolar ridges, Angle's class I maxillomandibular relations, available maxillary restorative space. This will be verified by tentative jaw relation records.
Key exclusion criteria (1 listed)
- All detrimental bad habits like smoking, TMJ clicking or TMJ dysfunction will be excluded.
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 supported hybrid maxillary prosthesisAll patients will receive immediately loaded hybrid prosthesis supported by 4 zygomatic implants. | Device | quad zygomatic hybrid maxillary prosthesis |
Primary outcome
patient satisfaction
Time frame: one year
The patient satisfaction will be evaluated using the visual analog scale (VAS) questionnaire at base line, 6, and 12 months later
marginal implant bone loss
Time frame: one year
The implant marginal bone height changes will be measured radiographically at base line, 6, and 12 months later
1 secondary outcome
posterior area index
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 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 supported hybrid maxillary 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 1 inclusion and 1 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 11 Sep 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?
patient satisfaction (time frame: one 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?
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 Sep 2023.