Prosthesis DurabilityNCT06050213
Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?
A study testing Maxillary implant overdenture in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
This within -subject study will be conducted to evaluate the proper number of unsplinted implants ;( three, four and five implants) for the edentulous maxilla opposed by mandibular two-implant overdentures. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- Maxillary implant overdenture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jun 2022to 16 Jul 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- o Healthy and free from any systemic diseases that may interfere with the osseointegration of implants.
- Patients have completely edentulous maxilla for at least 6 months after last extraction with opposing mandibular two-implant Overdentures.
- The patients have angle class I maxillomandibular skeletal relation and sufficient interarch space not less than (10-12 mm) as detected by tentative jaw relation.
- Maxillary and mandibular alveolar ridges covered with healthy, firm, relatively even thickness and even compressible mucosa as detected by palpation with the blunt end of the mirror and free from any signs of inflammation or flabbiness as detected by clinical examination.
- Good quality and quantity of maxillary residual alveolar ridge, as detected by CBCT, available for implant width (3.7mm, 5mm for anterior and posterior implants respectively) and length (12mm, 10mm for anterior and posterior implants respectively) this was ascertained by CBCT.
Who cannot join
- o Any history of metabolic or systemic diseases that may affect integration of implant or connective tissue health surrounding implant.
- History of irradiation in head-and-neck area.
- Heavy smokers (more than 10 cigarettes per day)
- Parafunctional habits such as bruxism.
- Psychiatric disorders or unrealistic expectations.
- Positive pregnancy test up to 5 days before surgery.
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- Severe thrombocytopenia and bleeding disorders.
- Pathologic condition of soft tissue (bacterial and viral stomatitis, hyperplasia, cyst, fibrous lesions)
- Patients with local contraindications for implant placement due to localized bone defects and poor bone quality (D5).
- Patients with TMJ disorders or poor neuromuscular coordination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maxillary Overdenture Retained by Different Number of Implants Opposed by 2-implant Assisted Mandibular Overdenture. A Cross-over Study of Patient Satisfaction
This within -subject study will be conducted to evaluate the proper number of unsplinted implants ;( three, four and five implants) for the edentulous maxilla opposed by mandibular two-implant overdentures.
- Conditions
- Prosthesis Durability
- Being tested
- Maxillary implant overdenture
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary implant overdentureDevice
maxillary overdenture retained by different number of implants
| Study group | Role | What they receive |
|---|---|---|
| three implant group | Active comparator | Maxillary overdenture retained by 3 unsplinted implants in midline and canines regions. Receives: Device: Maxillary implant overdenture |
| five implant group | Active comparator | Maxillary overdenture retained by 5 unsplinted implants in midline, canines and molar regions. Receives: Device: Maxillary implant overdenture |
| four implant group | Active comparator | Maxillary overdenture retained by 4 unsplinted implants in canines and molar regions. Receives: Device: Maxillary implant overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
patient satisfaction will be evaluated for all patients by a questionnaire using visual analogue scale
Measured: one year
Bite force
Bite force will be evaluated for all patients by a digital bite force device
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 posted22 Sep 2023
- Study start8 Jun 2022
- Primary completion26 Dec 2023 (estimated)
- Study completion16 Jul 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
- NCT06050213
- Sponsor's protocol ID
- A20080622
- Status last verified
- Sep 2023
- First submitted
- 17 Sep 2023
- Last updated
- 22 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Overdenture Retained by Different Number of Implants Opposed by 2-implant Assisted Mandibular Overdenture. A Cross-over Study of Patient Satisfaction
- ClinicalTrials.gov ID
- NCT06050213
- Acronym / sponsor ID
- A20080622
- Conditions
- Prosthesis Durability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 26 Dec 2023 (estimated)
- Study completion
- 16 Jul 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 within -subject study will be conducted to evaluate the proper number of unsplinted implants ;( three, four and five implants) for the edentulous maxilla opposed by mandibular two-implant overdentures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| three implant group | Active comparator | Device: Maxillary implant overdentureMaxillary overdenture retained by 3 unsplinted implants in midline and canines regions. |
| five implant group | Active comparator | Device: Maxillary implant overdentureMaxillary overdenture retained by 5 unsplinted implants in midline, canines and molar regions. |
| four implant group | Active comparator | Device: Maxillary implant overdentureMaxillary overdenture retained by 4 unsplinted implants in canines and molar regions. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- o Healthy and free from any systemic diseases that may interfere with the osseointegration of implants.
Key exclusion criteria (10 listed)
- o Any history of metabolic or systemic diseases that may affect integration of implant or connective tissue health surrounding implant.
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 |
|---|---|---|
| Maxillary implant overdenturemaxillary overdenture retained by different number of implants | Device | five implant group, four implant group, three implant group |
Primary outcome
Patient satisfaction
Time frame: one year
patient satisfaction will be evaluated for all patients by a questionnaire using visual analogue scale
Bite force
Time frame: one year
Bite force will be evaluated for all patients by a digital bite force device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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 Maxillary implant overdenture 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 5 inclusion and 10 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 22 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 22 Sep 2023.