Prosthesis DurabilityNCT05912127
All on Four Versus All on Three Implant Treatment Concepts
A study testing implant supported fixed full arch prosthesis in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
the evaluation of patient satisfaction of All on-4 versus All on-3 implant treatment concepts rehabilitation of atrophied mandibular ridge. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- implant supported fixed full arch prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2022to 11 Jun 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. All patients already have implants inserted in their mandibular ridges According to the All on 4 or All on 3 concepts.
- 2. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetes or osteoporosis. This was achieved through medical history and clinical examination by the physician.
- 3. All patients have sufficient inter-arch space. 4. All patients are of angle class I maxillo-mandibular relationships. 5. All patients had maxillary conventional complete dentures.
Who cannot join
- 1. Any neuromuscular disorders 2. Uncooperative patients
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: All On-4 Versus All o-3 Implant Treatment Concepts for Rehabilitation of Atrophied Mandibular Ridge. A Study of Patient Satisfaction
the evaluation of patient satisfaction of All on-4 versus All on-3 implant treatment concepts rehabilitation of atrophied mandibular ridge.
Read the detailed description
Patients will be classified into 2 groups according to the implant treatment concept they received:
- Group 1 (control group); included patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.
- Group 2 (test group); included patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.
- Conditions
- Prosthesis Durability
- Being tested
- implant supported fixed full arch 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 fixed full arch prosthesisDevice
the patients will receive screw-retained cast metal-ceramic fixed prostheses that replace lost gingival tissues with pink porcelain.
| Study group | Role | What they receive |
|---|---|---|
| • Group 1 (control group) | Active comparator | patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas. Receives: Device: implant supported fixed full arch prosthesis |
| • Group 2 (test group); | Active comparator | patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible. Receives: Device: implant supported fixed full arch prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Patient satisfaction was evaluated using a questionnaire based on visual analog scale (VAS)
Measured: one year
crestal bone loss
bone loss was measured around the implants in mm
Measured: Two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start16 Jan 2022
- Primary completion9 Oct 2022
- Study completion11 Jun 2023
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
- Parallel groups
- Model description
- Patients will be classified into 2 groups according to the implant treatment concept they received: * Group 1 (control group); included 3 patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas. * Group 2 (test group); included 3 patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mostafa Elsyad, professor, Principal investigator, professor of prosthodontics, Faculty of dentistry , Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912127
- Sponsor's protocol ID
- A09071221
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All On-4 Versus All o-3 Implant Treatment Concepts for Rehabilitation of Atrophied Mandibular Ridge. A Study of Patient Satisfaction
- ClinicalTrials.gov ID
- NCT05912127
- Acronym / sponsor ID
- A09071221
- Conditions
- Prosthesis Durability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 16 Jan 2022 (actual)
- Primary completion
- 9 Oct 2022 (actual)
- Study completion
- 11 Jun 2023 (actual)
- First posted
- 22 Jun 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 evaluation of patient satisfaction of All on-4 versus All on-3 implant treatment concepts rehabilitation of atrophied mandibular ridge.
Detailed description
Patients will be classified into 2 groups according to the implant treatment concept they received:
- Group 1 (control group); included patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.
- Group 2 (test group); included patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be classified into 2 groups according to the implant treatment concept they received: * Group 1 (control group); included 3 patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas. * Group 2 (test group); included 3 patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.
| Arm | Type | Receives |
|---|---|---|
| • Group 1 (control group) | Active comparator | Device: implant supported fixed full arch prosthesispatients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas. |
| • Group 2 (test group); | Active comparator | Device: implant supported fixed full arch prosthesispatients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. All patients already have implants inserted in their mandibular ridges According to the All on 4 or All on 3 concepts.
- 2. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetes or osteoporosis. This was achieved through medical history and clinical examination by the physician.
- 3. All patients have sufficient inter-arch space. 4. All patients are of angle class I maxillo-mandibular relationships. 5. All patients had maxillary conventional complete dentures.
Key exclusion criteria (2 listed)
- 1. Any neuromuscular disorders 2. Uncooperative patients
- -
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 fixed full arch prosthesisthe patients will receive screw-retained cast metal-ceramic fixed prostheses that replace lost gingival tissues with pink porcelain. | Device | • Group 1 (control group), • Group 2 (test group); |
Primary outcome
patient satisfaction
Time frame: one year
Patient satisfaction was evaluated using a questionnaire based on visual analog scale (VAS)
crestal bone loss
Time frame: Two year
bone loss was measured around the implants in mm
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 22 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Mostafa Elsyad, professor principal investigator
professor of prosthodontics, Faculty of dentistry , Mansoura University
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 fixed full arch 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 3 inclusion and 2 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 22 Jun 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?
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?
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 Jun 2023.