Complete EdentulismNCT07701200
OT-Bridge System Versus Multiunit Abutment for Mandibular All On-4 Screw Retained Prostheses.
A study testing OT-Bridge and Multiunit in people with Complete Edentulism and All-on-4, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to compare two different prosthetic systems used in mandibular full-arch implant-supported fixed prostheses (All-on-4). The study evaluates patient satisfaction and prosthetic complications associated with the OT-Bridge system versus multiunit abutments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism, All-on-4, Implant Supported Prosthesis
- What is being tested?
- OT-Bridge and Multiunit
- 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
- 13 Dec 2023to 10 Jul 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) with edentulous mandible.
- Patients receiving or having received All-on-4 dental implants in the mandible.
- Adequate implant stability to support prosthetic loading.
- Patients indicated for screw-retained full-arch fixed prostheses using either OT-Bridge system or multiunit abutments.
- Patients willing to participate and attend follow-up visits at T0, T6, and T12 months.
Who cannot join
- Patients with uncontrolled systemic conditions affecting healing (e.g., uncontrolled diabetes).
- Patients with failed or mobile implants.
- Severe parafunctional habits (e.g., uncontrolled bruxism).
- Poor oral hygiene compliance.
- Patients unable to attend follow-up visits
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ministry of Health and Population, Egypt - Kafr Demira Health Unit
Al Mansurah, 00000
About this study
Official title: Patient Satisfaction and Prosthetic Complication of OT-Bridge System Versus Multiunit Abutment for Mandibular All On-4 Screw Retained Prostheses.
This study aims to compare two different prosthetic systems used in mandibular full-arch implant-supported fixed prostheses (All-on-4). The study evaluates patient satisfaction and prosthetic complications associated with the OT-Bridge system versus multiunit abutments.
A total of 20 patients will be included and divided into two equal groups. All patients will receive implant-supported screw-retained fixed prostheses.
Read more
Clinical and prosthetic outcomes will be assessed at baseline (T0), 6 months (T6), and 12 months (T12), including evaluation of patient satisfaction and any prosthetic complications.
The findings of this study may help improve the selection of prosthetic systems to enhance clinical outcomes and patient quality of life.
- Conditions
- Complete Edentulism, All-on-4, Implant Supported Prosthesis, Multiunnit Abutments, OT- Bridge
- Being tested
- OT-Bridge, Multiunit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT-BridgeDevice
OT-Bridge system is a prosthetic attachment system used for implant-supported fixed full-arch prostheses. It is designed to connect implants and provide a screw-retained restoration for mandibular All-on-4 cases, allowing improved prosthetic stability and passive fit.
MultiunitDevice
Multiunit abutments are prosthetic components used in implant-supported full-arch fixed prostheses. They are placed on dental implants to correct angulation and provide a stable platform for screw-retained mandibular All-on-4 restorations.
| Study group | Role | What they receive |
|---|---|---|
| OT- Bridge System | Experimental | Patients receiving OT-Bridge prosthetic system in mandibular All-on-4 Receives: Device: OT-Bridge |
| Multiunit Abutment Group | Active comparator | Patients receiving multiunit abutments in mandibular All-on-4 Receives: Device: Multiunit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient satisfaction will be assessed using a structured questionnaire for patients receiving mandibular All-on-4 implant-supported fixed prostheses. Satisfaction will be evaluated at baseline (T0), 6 months (T6), and 12 months (T12) after prosthesis delivery, comparing OT-Bridge system and multiunit abutments.
Measured: Baseline, 6 months, 12 months
Prosthetic Complications
Prosthetic complications will be recorded for both groups, including screw loosening, prosthesis fracture, loss of retention, and need for maintenance or adjustment. Evaluations will be performed at T0, T6, and T12 months in mandibular All-on-4 implant-supported prostheses.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start13 Dec 2023
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Adel Ghazi, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701200
- Sponsor's protocol ID
- A06012023RP
- Status last verified
- Dec 2023
- First submitted
- 10 May 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Prosthetic Complication of OT-Bridge System Versus Multiunit Abutment for Mandibular All On-4 Screw Retained Prostheses.
- ClinicalTrials.gov ID
- NCT07701200
- Acronym / sponsor ID
- A06012023RP
- Conditions
- Complete Edentulism, All-on-4, Implant Supported Prosthesis, Multiunnit Abutments, OT- Bridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 14 Jul 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 compare two different prosthetic systems used in mandibular full-arch implant-supported fixed prostheses (All-on-4). The study evaluates patient satisfaction and prosthetic complications associated with the OT-Bridge system versus multiunit abutments.
A total of 20 patients will be included and divided into two equal groups. All patients will receive implant-supported screw-retained fixed prostheses.
Clinical and prosthetic outcomes will be assessed at baseline (T0), 6 months (T6), and 12 months (T12), including evaluation of patient satisfaction and any prosthetic complications.
The findings of this study may help improve the selection of prosthetic systems to enhance clinical outcomes and patient quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OT- Bridge System | Experimental | Device: OT-BridgePatients receiving OT-Bridge prosthetic system in mandibular All-on-4 |
| Multiunit Abutment Group | Active comparator | Device: MultiunitPatients receiving multiunit abutments in mandibular All-on-4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥18 years) with edentulous mandible.
- Patients receiving or having received All-on-4 dental implants in the mandible.
- Adequate implant stability to support prosthetic loading.
- Patients indicated for screw-retained full-arch fixed prostheses using either OT-Bridge system or multiunit abutments.
- Patients willing to participate and attend follow-up visits at T0, T6, and T12 months.
Key exclusion criteria (5 listed)
- Patients with uncontrolled systemic conditions affecting healing (e.g., uncontrolled diabetes).
- Patients with failed or mobile implants.
- Severe parafunctional habits (e.g., uncontrolled bruxism).
- Poor oral hygiene compliance.
- Patients unable to attend follow-up visits
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 |
|---|---|---|
| OT-BridgeOT-Bridge system is a prosthetic attachment system used for implant-supported fixed full-arch prostheses. It is designed to connect implants and provide a screw-retained restoration for mandibular All-on-4 cases, allowing improved prosthetic stability and passive fit. | Device | OT- Bridge System |
| MultiunitMultiunit abutments are prosthetic components used in implant-supported full-arch fixed prostheses. They are placed on dental implants to correct angulation and provide a stable platform for screw-retained mandibular All-on-4 restorations. | Device | Multiunit Abutment Group |
Primary outcome
Patient Satisfaction
Time frame: Baseline, 6 months, 12 months
Patient satisfaction will be assessed using a structured questionnaire for patients receiving mandibular All-on-4 implant-supported fixed prostheses. Satisfaction will be evaluated at baseline (T0), 6 months (T6), and 12 months (T12) after prosthesis delivery, comparing OT-Bridge system and multiunit abutments.
Prosthetic Complications
Time frame: Baseline, 6 months, 12 months
Prosthetic complications will be recorded for both groups, including screw loosening, prosthesis fracture, loss of retention, and need for maintenance or adjustment. Evaluations will be performed at T0, T6, and T12 months in mandibular All-on-4 implant-supported prostheses.
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 14 Jul 2026.
- 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 OT-Bridge and Multiunit in people with Complete Edentulism and All-on-4, 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 5 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 14 Jul 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?
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: Baseline, 6 months, 12 months). 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 14 Jul 2026.