Evaluate the Immediate Loading Implants in All on 4 Cases Using Conversion Denture and OT Bridge SystemOTBSNCT05031156
Splinted and Unsplinted OT Bridge Systems in Screw Retained Implant Restoration
A study testing Splinting of OT Bridge system in people with Evaluate the Immediate Loading Implants in All on 4 Cases Using Conversion Denture and OT Bridge System, run by Cairo University.
Trial summary
Evaluation of Bone level changes around dental implants in All on 4 cases with immediate loading using conversion denture and OT Bridge system either splinted or not Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluate the Immediate Loading Implants in All on 4 Cases Using Conversion Denture and OT Bridge System
- What is being tested?
- Splinting of OT Bridge system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2021to 7 Jun 2022
- 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
- Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.
- Patients aged from 40 to 70, able to sign an informed consent will be considered eligible for this trial.
- Implant sites must allow the placement of four implants.
- Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
- In case of post-extractive sites, they must have been healed for at least 3-month before being treated in the study.
- Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates)
Who cannot join
- - Patients with poor oral hygiene and motivation.
- Pregnancy or nursing.
- Drug abusers.
- Psychiatric problems or unrealistic expectations.
- Patients with infection and or inflammation in the area intended for implant placement.
- Patients participating in other studies, if the present protocol cannot be properly adhered to.
- Patients with signs of hyperactive muscles.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Mandibular Immediately Loaded, Screw-retained Splinted and Non-splinted OT Bridge Implant Restoration on Bone Height Changes of Completely Edentulous Patients (A Randomized Clinical Trial)
Evaluation of Bone level changes around dental implants in All on 4 cases with immediate loading using conversion denture and OT Bridge system either splinted or not
- Being tested
- Splinting of OT Bridge system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splinting of OT Bridge systemProcedure or surgery
splinting of implant abutment using titanium wire followed by pick up using the patient's denture
| Study group | Role | What they receive |
|---|---|---|
| non-splinting of OT Bridge system | Active comparator | Leaving the dental implants abutments solitary followed by denture pick up Receives: Procedure: Splinting of OT Bridge system |
| splinting of OT Bridge | Experimental | Splinting of implants abutments using titanium wire then followed by denture pick up Receives: Procedure: Splinting of OT Bridge system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone loss
Measures the changes around the dental implants along the healing period using paralleling technique radiograph and DIGORA system
Measured: 3 monts
Secondary outcomes (1)
Early implant failure
not fulfilling one of Alberksston implant success criteria
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start30 Sep 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion7 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the Immediate Loading Implants in All on 4 Cases Using Conversion Denture and OT Bridge SystemStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tasneem gamal youssef el mashad, Cairo University
- Investigators
- Tasneem El Mashad, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031156
- Sponsor's protocol ID
- OTBridge
- Acronym
- OTBS
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mandibular Immediately Loaded, Screw-retained Splinted and Non-splinted OT Bridge Implant Restoration on Bone Height Changes of Completely Edentulous Patients (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05031156
- Acronym / sponsor ID
- OTBS / OTBridge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 7 Jun 2022 (estimated)
- First posted
- 1 Sep 2021 (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.
Evaluation of Bone level changes around dental implants in All on 4 cases with immediate loading using conversion denture and OT Bridge system either splinted or not
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-splinting of OT Bridge system | Active comparator | Procedure: Splinting of OT Bridge systemLeaving the dental implants abutments solitary followed by denture pick up |
| splinting of OT Bridge | Experimental | Procedure: Splinting of OT Bridge systemSplinting of implants abutments using titanium wire then followed by denture pick up |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.
- Patients aged from 40 to 70, able to sign an informed consent will be considered eligible for this trial.
- Implant sites must allow the placement of four implants.
- Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
- In case of post-extractive sites, they must have been healed for at least 3-month before being treated in the study.
Key exclusion criteria (7 listed)
- - Patients with poor oral hygiene and motivation.
- Pregnancy or nursing.
- Drug abusers.
- Psychiatric problems or unrealistic expectations.
- Patients with infection and or inflammation in the area intended for implant placement.
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 |
|---|---|---|
| Splinting of OT Bridge systemsplinting of implant abutment using titanium wire followed by pick up using the patient's denture | Procedure or surgery | non-splinting of OT Bridge system, splinting of OT Bridge |
Primary outcome
Marginal Bone loss
Time frame: 3 monts
Measures the changes around the dental implants along the healing period using paralleling technique radiograph and DIGORA system
1 secondary outcome
Early implant failure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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.
Tasneem El Mashad principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Splinting of OT Bridge system in people with Evaluate the Immediate Loading Implants in All on 4 Cases Using Conversion Denture and OT Bridge System, run by Cairo University.
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 6 inclusion and 7 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 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Tasneem El Mashad, Master degree holder (01005754571 ext. +02, tasneem.elmashad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal Bone loss (time frame: 3 monts). 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 1 Sep 2021.