Reconstructed JawsNCT03950284
Assessment of the Stability of Immediately Loaded All-on-four Dental Implants in FFF Used for Reconstruction of the Jaws
A study testing immediate loading with all on four technique in FFF in people with Reconstructed Jaws and Free Fibula Flaps, run by Cairo University at 1 site in Egypt.
Trial summary
The use of free vascularized fibula flaps for bony reconstruction has proved its success as a substitution for the resected bone and in some instances, the surrounding soft tissues The aim of this case series study is to evaluate the stability of the dental implants placed in free fibula flaps substituting a resected… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Reconstructed Jaws, Free Fibula Flaps, All on Four Technique
- What is being tested?
- immediate loading with all on four technique in FFF
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2019to 20 May 2021
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with reconstructed jaws with free fibula flaps in either or both jaws.
- Age group : from 15 to 60 years old
- No sex predilection
- Patients with no contraindications to surgical intervention Exclusion Criteria
- Patients with systemic condition counteracting with the surgical procedure.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Stability of Immediately Loaded Dental Implants With the All-on-four Technique in Free Vascularized Fibular Grafts Used for Reconstruction of the Jaws
The use of free vascularized fibula flaps for bony reconstruction has proved its success as a substitution for the resected bone and in some instances, the surrounding soft tissues
The aim of this case series study is to evaluate the stability of the dental implants placed in free fibula flaps substituting a resected mandible and/or maxilla when they are immediately loaded with the All-On-Four technique along with the patient satisfaction.
Read the detailed description
- Preoperative phase :
Patients will be subjected to:
- Case history including personal data, medical, surgical and family history.
- Clinical examination
- Radiographic examination using computed tomography (C.T) bony and soft tissue window.
- Diagnostic studying casts.
- Operative phase :
All cases will undergo surgery under local regional anesthesia. Injection of local anaesthesia (Articaine 4% and 1:100000 epinephrine) for regional infiltration. Sequential drilling then insertion of the dental implant fixtures and abutments on which the prefabricated temporary prosthesis will be fixed.
- Postoperative care Proper postoperative instructions will be given to the patient such as strict oral hygiene measures and soft diet for 1 month, in addition to the postoperative medications including antibiotics (amoxicillin 1g capsules b.d.s ) and analgesics (diclofenac potassium 50mg as needed). Adherence to follow ups will be also instructed
- Conditions
- Reconstructed Jaws, Free Fibula Flaps, All on Four Technique
- Being tested
- immediate loading with all on four technique in FFF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate loading with all on four technique in FFFDevice
All cases will undergo surgery under local regional anesthesia. Injection of local anaesthesia (Articaine 4% and 1:100000 epinephrine) for regional infiltration. Sequential drilling then insertion of the dental implant fixtures and abutments on which the prefabricated temporary prosthesis will be fixed.
| Study group | Role | What they receive |
|---|---|---|
| immediate loading with all on four technique in FFF | Experimental | immediately loaded dental implants with the all-on-four technique in free vascularized fibular grafts Receives: Device: immediate loading with all on four technique in FFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Stability
The primary outcome is the implant stability determined by the insertion torque at the time of insertion using OSSTELL device
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start30 May 2019
- Primary completion30 Apr 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructed JawsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shawky, Cairo University
- Investigators
- Mohamed Shawky, MSc, Principal investigator, Assistant lecturer. OMFS. Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950284
- Sponsor's protocol ID
- cairo omfs masters
- Status last verified
- Aug 2021
- First submitted
- 13 May 2019
- Last updated
- 6 Aug 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 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Stability of Immediately Loaded Dental Implants With the All-on-four Technique in Free Vascularized Fibular Grafts Used for Reconstruction of the Jaws
- ClinicalTrials.gov ID
- NCT03950284
- Acronym / sponsor ID
- cairo omfs masters
- Conditions
- Reconstructed Jaws, Free Fibula Flaps, All on Four Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 15 May 2019 (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 use of free vascularized fibula flaps for bony reconstruction has proved its success as a substitution for the resected bone and in some instances, the surrounding soft tissues
The aim of this case series study is to evaluate the stability of the dental implants placed in free fibula flaps substituting a resected mandible and/or maxilla when they are immediately loaded with the All-On-Four technique along with the patient satisfaction.
Detailed description
- Preoperative phase :
Patients will be subjected to:
- Case history including personal data, medical, surgical and family history.
- Clinical examination
- Radiographic examination using computed tomography (C.T) bony and soft tissue window.
- Diagnostic studying casts.
- Operative phase :
All cases will undergo surgery under local regional anesthesia. Injection of local anaesthesia (Articaine 4% and 1:100000 epinephrine) for regional infiltration. Sequential drilling then insertion of the dental implant fixtures and abutments on which the prefabricated temporary prosthesis will be fixed.
- Postoperative care Proper postoperative instructions will be given to the patient such as strict oral hygiene measures and soft diet for 1 month, in addition to the postoperative medications including antibiotics (amoxicillin 1g capsules b.d.s ) and analgesics (diclofenac potassium 50mg as needed). Adherence to follow ups will be also instructed
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immediate loading with all on four technique in FFF | Experimental | Device: immediate loading with all on four technique in FFFimmediately loaded dental implants with the all-on-four technique in free vascularized fibular grafts |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with reconstructed jaws with free fibula flaps in either or both jaws.
- Age group : from 15 to 60 years old
- No sex predilection
- Patients with no contraindications to surgical intervention Exclusion Criteria
- Patients with systemic condition counteracting with the surgical procedure.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| immediate loading with all on four technique in FFFAll cases will undergo surgery under local regional anesthesia. Injection of local anaesthesia (Articaine 4% and 1:100000 epinephrine) for regional infiltration. Sequential drilling then insertion of the dental implant fixtures and abutments on which the prefabricated temporary prosthesis will be fixed. | Device | immediate loading with all on four technique in FFF |
Primary outcome
Primary Stability
Time frame: 6 months
The primary outcome is the implant stability determined by the insertion torque at the time of insertion using OSSTELL device
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 6 Aug 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.
Mohamed Shawky, MSc principal investigator
Assistant lecturer. OMFS. Cairo 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 immediate loading with all on four technique in FFF in people with Reconstructed Jaws and Free Fibula Flaps, run by Cairo 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 0 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 6 Aug 2021. 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?
Primary Stability (time frame: 6 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 6 Aug 2021.