Immediate Loading , Satellite Implant , Immediate ImplantNCT05782634
Insertion of Immediate Cortical Satellite Implants With Immediate Loading
A study testing immediate satellite implant with immediate loading in people with Immediate Loading , Satellite Implant , Immediate Implant, run by Cairo University at 1 site in Egypt.
Trial summary
Statement of the problem: Based on the literature traditional immediate implant with immediate loading has high failure rate due to destructive horizontal forces, accordingly It was recommended for long time stress-free healing periods to achieve the osseointegration of dental implants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Loading , Satellite Implant , Immediate Implant
- What is being tested?
- immediate satellite implant with immediate loading
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Aug 2024
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients seeking implant drive prosthesis after immediate extraction technique .
- Fresh extraction sockets with undestructed labial or palatal walls.
- Patients with non-restorable teeth due to untreatable caries or trauma.
Who cannot join
- General contraindications to implant surgery.
- Active infection or severe inflammation in the area intended for implant placement
- Teeth non restorable due to periodontal issues.
- Poor oral hygiene and motivation.
- Pregnant or nursing.
- Substance abuse.
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- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Patients participating in other studies, if the present protocol could not be properly followed
Trial locations and contacts
1 site in 1 country.
Mohammed omaraa, lecturer contact
About this study
Official title: Insertion of Immediate Cortical Satellite Implants With Immediate Loading in the Maxillary Esthetic Zone, a Case Series Study
Statement of the problem:
Based on the literature traditional immediate implant with immediate loading has high failure rate due to destructive horizontal forces, accordingly It was recommended for long time stress-free healing periods to achieve the osseointegration of dental implants.
Read more
But unfortunately this long time to restore the missing teeth is unsatisfactory to the patient due to high increase of patients' demand for perfect restoring missing teeth preservation of soft and hard tissues with better esthetic and functional results with decreasing the treatment plan time.
Rationale for conducting the research:
This study aimed to add a satellite implant device around the root form implant to enhance the primary implant stability for immediate loading followed by assessment of the final implant stability and final bone quantity and quality around the placed implant
Read the detailed description
Research question:
Does the use of satellite implant technique for immediate loading will effectively reduce the treatment time without affection of the final implant stability and the final bone quality and quantity around the placed root form dental implant?
Statement of the problem:
Based on the literature traditional immediate implant with immediate loading has high failure rate due to destructive horizontal forces, accordingly It was recommended for long time stress-free healing periods to achieve the osseointegration of dental implants.
But unfortunately this long time to restore the missing teeth is unsatisfactory to the patient due to high increase of patients' demand for perfect restoring missing teeth preservation of soft and hard tissues with better esthetic and functional results with decreasing the treatment plan time.
Rationale for conducting the research:
This study aimed to add a satellite implant device around the root form implant to enhance the primary implant stability for immediate loading followed by assessment of the final implant stability and final bone quantity and quality around the placed implant
Review of literature:
A long time before there is increase of the patient demand for perfect restoring missing teeth with reducing the total time of treatment over all. So immediate loading implant was a very good solution especially in esthetic zone . However , it is not always applicable due to the difficult surrounding circumcenters Such like unfavorable type or quality of bone which makes immediate implant is impossible. Osseointegration of an implant, which is the main treatment goal, might best be understood to simply mean "undisturbed bone healing around the implant." Micro motion probably interferes with the development of an adequate early scaffold from the fibrin clot . Biomechanically, implants to be loaded immediately need to be stable and resistant to macro movement to ensure good osseointegration. Enhancement of implant stability can be achieved primarily by using a connecting bar as a stabilizer to provide a polygonal support to distribute forces and moments on single standing implants . This study aimed to add a satellite plate around the root form implant to enhance the primary implant stability for immediate loading followed by assessment of the final implant stability and final bone quantity and quality around the placed implant.
Objectives:
This study aimed to evaluate the final implant stability and bone condition after the use of satellite immediate implant with immediate loading in fresh extraction sockets.
- Being tested
- immediate satellite implant with immediate loading
- Keywords
- immediate loading , satellite implant , immediate implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate satellite implant with immediate loadingDevice
Infiltration anesthesia will be administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 . Injection to control pain and bleeding for hemostasis.
Dental extraction will be done with minimal force to avoid trauma to the bone. Flab will be released, different drilling sizes will be used to attain the final drill size of the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, a satellite implant device is attached to the implant's abutment placed on the buccal and palatal plates of bone and retention between the abutment and microplate will help in neglecting the lateral destructive forces . sutures will be done . Impression will be taken for immediate loading with the final crown. Cone beam will be done.
| Study group | Role | What they receive |
|---|---|---|
| subjected to immediate cortical satellite implants with immediate loading | Experimental | All patients involved in this study will be subjected to immediate cortical satellite implants with immediate loading Receives: Device: immediate satellite implant with immediate loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
final implant stability after satellite implant device removal.
OUT COME
Calculate the final implant stability after plate removal.
MEASURE DEVICE Osstell "resonance frequency analyzer"
MEASURE UNIT ISQ
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 posted23 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Loading , Satellite Implant , Immediate ImplantStudies 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Essam Mohamed Mahmoud, Cairo University
- Investigators
- salah yassin, professor, Principal investigator, • Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo UniversityMohammed omaraa, lecturer, Study director, • Lecturer in Oral and Maxillofacial Surgery- Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782634
- Sponsor's protocol ID
- essam95
- Status last verified
- May 2023
- First submitted
- 11 Mar 2023
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insertion of Immediate Cortical Satellite Implants With Immediate Loading in the Maxillary Esthetic Zone, a Case Series Study
- ClinicalTrials.gov ID
- NCT05782634
- Acronym / sponsor ID
- essam95
- Keywords
- immediate loading , satellite implant , immediate implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 23 Mar 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.
Statement of the problem:
Based on the literature traditional immediate implant with immediate loading has high failure rate due to destructive horizontal forces, accordingly It was recommended for long time stress-free healing periods to achieve the osseointegration of dental implants.
But unfortunately this long time to restore the missing teeth is unsatisfactory to the patient due to high increase of patients' demand for perfect restoring missing teeth preservation of soft and hard tissues with better esthetic and functional results with decreasing the treatment plan time.
Rationale for conducting the research:
This study aimed to add a satellite implant device around the root form implant to enhance the primary implant stability for immediate loading followed by assessment of the final implant stability and final bone quantity and quality around the placed implant
Detailed description
Research question:
Does the use of satellite implant technique for immediate loading will effectively reduce the treatment time without affection of the final implant stability and the final bone quality and quantity around the placed root form dental implant?
Statement of the problem:
Based on the literature traditional immediate implant with immediate loading has high failure rate due to destructive horizontal forces, accordingly It was recommended for long time stress-free healing periods to achieve the osseointegration of dental implants.
But unfortunately this long time to restore the missing teeth is unsatisfactory to the patient due to high increase of patients' demand for perfect restoring missing teeth preservation of soft and hard tissues with better esthetic and functional results with decreasing the treatment plan time.
Rationale for conducting the research:
This study aimed to add a satellite implant device around the root form implant to enhance the primary implant stability for immediate loading followed by assessment of the final implant stability and final bone quantity and quality around the placed implant
Review of literature:
A long time before there is increase of the patient demand for perfect restoring missing teeth with reducing the total time of treatment over all. So immediate loading implant was a very good solution especially in esthetic zone . However , it is not always applicable due to the difficult surrounding circumcenters Such like unfavorable type or quality of bone which makes immediate implant is impossible. Osseointegration of an implant, which is the main treatment goal, might best be understood to simply mean "undisturbed bone healing around the implant." Micro motion probably interferes with the development of an adequate early scaffold from the fibrin clot . Biomechanically, implants to be loaded immediately need to be stable and resistant to macro movement to ensure good osseointegration. Enhancement of implant stability can be achieved primarily by using a connecting bar as a stabilizer to provide a polygonal support to distribute forces and moments on single standing implants . This study aimed to add a satellite plate around the root form implant to enhance the primary implant stability for immediate loading followed by assessment of the final implant stability and final bone quantity and quality around the placed implant.
Objectives:
This study aimed to evaluate the final implant stability and bone condition after the use of satellite immediate implant with immediate loading in fresh extraction sockets.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjected to immediate cortical satellite implants with immediate loading | Experimental | Device: immediate satellite implant with immediate loadingAll patients involved in this study will be subjected to immediate cortical satellite implants with immediate loading |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients seeking implant drive prosthesis after immediate extraction technique .
- Fresh extraction sockets with undestructed labial or palatal walls.
- Patients with non-restorable teeth due to untreatable caries or trauma.
Key exclusion criteria (11 listed)
- General contraindications to implant surgery.
- Active infection or severe inflammation in the area intended for implant placement
- Teeth non restorable due to periodontal issues.
- Poor oral hygiene and motivation.
- Pregnant or nursing.
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 satellite implant with immediate loadingInfiltration anesthesia will be administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 . Injection to control pain and bleeding for hemostasis. Dental extraction will be done with minimal force to avoid trauma to the bone. Flab will be released, different drilling sizes will be used to attain the final drill size of the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, a satellite implant device is attached to the implant's abutment placed on the buccal and palatal plates of bone and retention between the abutment and microplate will help in neglecting the lateral destructive forces . sutures will be done . Impression will be taken for immediate loading with the final crown. Cone beam will be done. | Device | subjected to immediate cortical satellite implants with immediate loading |
Primary outcome
final implant stability after satellite implant device removal.
Time frame: 6 months
OUT COME Calculate the final implant stability after plate removal. MEASURE DEVICE Osstell "resonance frequency analyzer" MEASURE UNIT ISQ
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
Related trials for Immediate Loading , Satellite Implant , Immediate Implant
Not yet recruiting
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
Novel Implant for Immediate Load in Posterior Mandible
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.
Mohammed omaraa, lecturer contact
salah yassin, professor principal investigator
• Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University
Mohammed omaraa, lecturer study director
• Lecturer in Oral and Maxillofacial Surgery- 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 satellite implant with immediate loading in people with Immediate Loading , Satellite Implant , Immediate Implant, 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 3 inclusion and 11 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 10 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact esraa essam, B.D.S (01009518350, esraa.essam@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
final implant stability after satellite implant device removal. (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 10 May 2023.