Jaw EdentulousNCT07632885
Patient Satisfaction and Prosthetic Complications of the Milled Bar Versus Screw-Retained Prostheses for Maxillary Subperiosteal Implants: A One Year Randomized Clinical Trial
A study testing Maxillary subperiosteal implant with milled bar-retained prosthesis and Maxillary subperiosteal implant with screw-retained prosthesis in people with Jaw Edentulous, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare patient satisfaction and prosthetic complications between two types of prostheses: milled bar and screw-retained prostheses, used for supporting maxillary subperiosteal implants. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Jaw Edentulous
- What is being tested?
- Maxillary subperiosteal implant with milled bar-retained prosthesis and Maxillary subperiosteal implant with screw-retained prosthesis
- 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
- 1 Jun 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe atrophied maxillary ridge (Residual bone height < 4mm on CBCT) with the presence of adequate bone volume in the maxilla to support subperiosteal implants.
- Willing to attend quarterly follow-ups.
- No previous subperiosteal implant history.
Who cannot join
- Systemic conditions contraindicating implant therapy.
- Poor oral hygiene or ongoing periodontal disease.
- Patients who have received hybrid restorations (i.e., a combination of bar and multi-unit systems).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry of Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
This study aims to evaluate and compare patient satisfaction and prosthetic complications between two types of prostheses: milled bar and screw-retained prostheses, used for supporting maxillary subperiosteal implants. Patients requiring maxillary rehabilitation using subperiosteal implants will be randomly assigned to receive either a milled bar-retained prosthesis or a screw-retained prosthesis. Patient satisfaction and any prosthetic complications will be clinical assessed and followed up over a one-year period to determine which prosthetic design offers better clinical outcomes and patient experience.
Read the detailed description
Patients enrolled in this randomized clinical trial will undergo surgical placement of maxillary subperiosteal implants. Following the healing period, patients will be allocated into two treatment groups. Group 1 will receive a milled bar-retained prosthesis, while Group 2 will receive a screw-retained prosthesis. Baseline data and clinical parameters will be recorded. Throughout the one-year follow-up period, patient satisfaction will be evaluated using standardized questionnaires or visual analog scales (VAS). Additionally, prosthetic complications-such as screw loosening, fracture, or bar-related issues-will be closely monitored and documented at regular follow-up intervals to comprehensively compare the two restorative modalities.
- Conditions
- Jaw Edentulous
- Being tested
- Maxillary subperiosteal implant with milled bar-retained prosthesis, Maxillary subperiosteal implant with screw-retained prosthesis
- Keywords
- Subperiosteal Implant, Milled Bar
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary subperiosteal implant with milled bar-retained prosthesisDevice
Also called Custom CAD/CAM subperiosteal implant overdenture
Surgical placement of a custom-milled, patient-specific CAD/CAM maxillary subperiosteal implant. Following the healing and provisional phase, a definitive milled bar-retained overdenture prosthesis will be fabricated and attached to support full-arch rehabilitation.
Maxillary subperiosteal implant with screw-retained prosthesisDevice
Surgical placement of a custom-milled, patient-specific CAD/CAM maxillary subperiosteal implant. Following the healing and provisional phase, a definitive screw-retained prosthesis will be fabricated and fixed to support full-arch rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Milled Bar-Retained Prosthesis | Experimental | Patients in this group will receive a milled bar-retained prosthesis supported by maxillary subperiosteal implants. Patient satisfaction and prosthetic complications will be evaluated over a one-year follow-up period. Receives: Device: Maxillary subperiosteal implant with milled bar-retained prosthesis |
| Group 2: Screw-Retained Prosthesis | Experimental | Patients in this group will receive a screw-retained prosthesis supported by maxillary subperiosteal implants. Patient satisfaction and prosthetic complications will be evaluated over a one-year follow-up period Receives: Device: Maxillary subperiosteal implant with screw-retained prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Complications
Aesthetic -mechanical -functional and biological categories
Measured: Baseline (immediately following prosthesis placement) and after one year
Patient satisfaction
Patient satisfaction will be evaluated using a Visual Analog Scale (VAS), where scores range from 0 to 10. A score of 0 represents complete dissatisfaction, while a score of 10 represents complete satisfaction with the prosthesis
Measured: Baseline (immediately following prosthesis placement) and after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw EdentulousStudies 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
- Participants will be randomly allocated into two parallel groups to receive either a milled bar-retained prosthesis or a screw-retained prosthesis
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632885
- Sponsor's protocol ID
- MDP.25.04.12
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Prosthetic Complications of the Milled Bar Versus Screw-Retained Prostheses for Maxillary Subperiosteal Implants: A One Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07632885
- Acronym / sponsor ID
- MDP.25.04.12
- Conditions
- Jaw Edentulous
- Keywords
- Subperiosteal Implant, Milled Bar
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Jun 2026 (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 aims to evaluate and compare patient satisfaction and prosthetic complications between two types of prostheses: milled bar and screw-retained prostheses, used for supporting maxillary subperiosteal implants. Patients requiring maxillary rehabilitation using subperiosteal implants will be randomly assigned to receive either a milled bar-retained prosthesis or a screw-retained prosthesis. Patient satisfaction and any prosthetic complications will be clinical assessed and followed up over a one-year period to determine which prosthetic design offers better clinical outcomes and patient experience.
Detailed description
Patients enrolled in this randomized clinical trial will undergo surgical placement of maxillary subperiosteal implants. Following the healing period, patients will be allocated into two treatment groups. Group 1 will receive a milled bar-retained prosthesis, while Group 2 will receive a screw-retained prosthesis. Baseline data and clinical parameters will be recorded. Throughout the one-year follow-up period, patient satisfaction will be evaluated using standardized questionnaires or visual analog scales (VAS). Additionally, prosthetic complications-such as screw loosening, fracture, or bar-related issues-will be closely monitored and documented at regular follow-up intervals to comprehensively compare the two restorative modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated into two parallel groups to receive either a milled bar-retained prosthesis or a screw-retained prosthesis
| Arm | Type | Receives |
|---|---|---|
| Group 1: Milled Bar-Retained Prosthesis | Experimental | Device: Maxillary subperiosteal implant with milled bar-retained prosthesisPatients in this group will receive a milled bar-retained prosthesis supported by maxillary subperiosteal implants. Patient satisfaction and prosthetic complications will be evaluated over a one-year follow-up period. |
| Group 2: Screw-Retained Prosthesis | Experimental | Device: Maxillary subperiosteal implant with screw-retained prosthesisPatients in this group will receive a screw-retained prosthesis supported by maxillary subperiosteal implants. Patient satisfaction and prosthetic complications will be evaluated over a one-year follow-up period |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe atrophied maxillary ridge (Residual bone height < 4mm on CBCT) with the presence of adequate bone volume in the maxilla to support subperiosteal implants.
- Willing to attend quarterly follow-ups.
- No previous subperiosteal implant history.
Key exclusion criteria (3 listed)
- Systemic conditions contraindicating implant therapy.
- Poor oral hygiene or ongoing periodontal disease.
- Patients who have received hybrid restorations (i.e., a combination of bar and multi-unit systems).
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 subperiosteal implant with milled bar-retained prosthesisAlso: Custom CAD/CAM subperiosteal implant overdentureSurgical placement of a custom-milled, patient-specific CAD/CAM maxillary subperiosteal implant. Following the healing and provisional phase, a definitive milled bar-retained overdenture prosthesis will be fabricated and attached to support full-arch rehabilitation. | Device | Group 1: Milled Bar-Retained Prosthesis |
| Maxillary subperiosteal implant with screw-retained prosthesisSurgical placement of a custom-milled, patient-specific CAD/CAM maxillary subperiosteal implant. Following the healing and provisional phase, a definitive screw-retained prosthesis will be fabricated and fixed to support full-arch rehabilitation. | Device | Group 2: Screw-Retained Prosthesis |
Primary outcome
Prosthetic Complications
Time frame: Baseline (immediately following prosthesis placement) and after one year
Aesthetic -mechanical -functional and biological categories
Patient satisfaction
Time frame: Baseline (immediately following prosthesis placement) and after one year
Patient satisfaction will be evaluated using a Visual Analog Scale (VAS), where scores range from 0 to 10. A score of 0 represents complete dissatisfaction, while a score of 10 represents complete satisfaction with the prosthesis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
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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 subperiosteal implant with milled bar-retained prosthesis and Maxillary subperiosteal implant with screw-retained prosthesis in people with Jaw Edentulous, 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 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: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prosthetic Complications (time frame: Baseline (immediately following prosthesis placement) and after 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 8 Jun 2026.