Prosthesis SurvivalNCT06114069
Prosthetic Management of All on Four Versus All on Six to Rehabilitate Completely Edentulous Maxillary Ridge Opposed by Natural Teeth
A study testing implant supported maxillary fixed prosthesis in people with Prosthesis Survival, run by Mansoura University at 1 site in Egypt.
Trial summary
the aim of the study to compare the anterior maxillary bone index changes for patient rehabilitated with implant supported fixed prosthesis opposed by natural teeth Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Survival
- What is being tested?
- implant supported maxillary fixed prosthesis
- 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
- 10 May 2022to 14 Aug 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. All patient wearing a maxillary implant supported overdenture or implant supported fixed restoration and mandibular natural teeth or fixed restoration within natural dentition.
- 2. All patients were unsatisfied by the maxillary restoration and presented clear preference for a better prosthesis.
- 3. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
- 4. At least one year passed after the last restoration. 5. At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna).195 This was detected by a tentative jaw relation.
Who cannot join
- 1. Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
- 2. Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders which might affect implant lifespan.
- 3. Long term immunosuppress and corticosteroid drug therapy. 4. Patient with abnormal habits as clenching and bruxism. 5. Smoking patient. 6. Uncooperative patients. 7. Neuromuscular diseases. 8. Patient with problems in TMJ.
Trial locations and contacts
1 site in 1 country.
About this study
the aim of the study to compare the anterior maxillary bone index changes for patient rehabilitated with implant supported fixed prosthesis opposed by natural teeth
- Conditions
- Prosthesis Survival
- Being tested
- implant supported maxillary fixed 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 maxillary fixed prosthesisProcedure or surgery
Maxillary fixed prosthesis according to all on four or all on six concept
| Study group | Role | What they receive |
|---|---|---|
| all on four group | Active comparator | 4 patients received 4-implant supported fixed prosthesis Receives: Procedure: implant supported maxillary fixed prosthesis |
| all on six group | Active comparator | 4 patients received 6-implant supported fixed prosthesis Receives: Procedure: implant supported maxillary fixed prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
anterior area index
outcome is being evaluated by radiograph
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start10 May 2022
- Primary completion14 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis SurvivalStudies 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
- Parallel groups
- Model description
- The patients were classified into 2 groups: 1. Group I; 4 patients received 4-implant supported fixed prosthesis. 2. Group II; 4 patients received 6-implant supported fixed prosthesis.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr ELsaeed, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114069
- Sponsor's protocol ID
- M07100522
- Status last verified
- Aug 2024
- First submitted
- 29 Oct 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Management of All on Four Versus All on Six to Rehabilitate Completely Edentulous Maxillary Ridge Opposed by Natural Teeth
- ClinicalTrials.gov ID
- NCT06114069
- Acronym / sponsor ID
- M07100522
- Conditions
- Prosthesis Survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 2 Nov 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.
the aim of the study to compare the anterior maxillary bone index changes for patient rehabilitated with implant supported fixed prosthesis opposed by natural teeth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The patients were classified into 2 groups: 1. Group I; 4 patients received 4-implant supported fixed prosthesis. 2. Group II; 4 patients received 6-implant supported fixed prosthesis.
| Arm | Type | Receives |
|---|---|---|
| all on four group | Active comparator | Procedure: implant supported maxillary fixed prosthesis4 patients received 4-implant supported fixed prosthesis |
| all on six group | Active comparator | Procedure: implant supported maxillary fixed prosthesis4 patients received 6-implant supported fixed prosthesis |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. All patient wearing a maxillary implant supported overdenture or implant supported fixed restoration and mandibular natural teeth or fixed restoration within natural dentition.
- 2. All patients were unsatisfied by the maxillary restoration and presented clear preference for a better prosthesis.
- 3. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
- 4. At least one year passed after the last restoration. 5. At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna).195 This was detected by a tentative jaw relation.
Key exclusion criteria (3 listed)
- 1. Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
- 2. Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders which might affect implant lifespan.
- 3. Long term immunosuppress and corticosteroid drug therapy. 4. Patient with abnormal habits as clenching and bruxism. 5. Smoking patient. 6. Uncooperative patients. 7. Neuromuscular diseases. 8. Patient with problems in TMJ.
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 maxillary fixed prosthesisMaxillary fixed prosthesis according to all on four or all on six concept | Procedure or surgery | all on four group, all on six group |
Primary outcome
anterior area index
Time frame: six months
outcome is being evaluated by radiograph
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 21 Nov 2024.
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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 maxillary fixed prosthesis in people with Prosthesis Survival, 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 4 inclusion and 3 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 21 Nov 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?
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?
anterior area index (time frame: six months). 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 21 Nov 2024.