Novel Implant for Immediate Load in Posterior MandibleNCT06486311
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
A study testing satellite implant in people with Novel Implant for Immediate Load in Posterior Mandible, run by Cairo University at 1 site in Egypt.
Trial summary
The research aims to evaluate the long-term effectiveness of satellite implants in the posterior mandible by assessing the levels of crestal bone after six months of first loading and secondary stability issues at fourth-month , primary stability at time of implant loading . Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Novel Implant for Immediate Load in Posterior Mandible
- What is being tested?
- satellite implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2025to 31 May 2027
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients requiring implants for the posterior mandible.
- Patients aged between 18-45 years old.
- Implants must be at least 8mm in length.
- A sufficient quantity and distribution of implants to enable cross-arch stability.
- Implants must have good initial stability, with insertion torques ranging from 35 to 50 N/cm.
- Sufficient bone for implant placement and plate fixation.
- Patient able to give informed consent.
- Sufficient inter-arch space.
Who cannot join
- Contraindications to implant surgery in general.
- Bruxism.
- Immunosuppression.
- History of radiation to the head and neck region.
- Uncontrolled diabetes.
- Heavy smokers (more than ten cigarettes per day).
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- Poor oral hygiene.
- Current or previous bisphosphonate therapy.
- Substance abuse.
- Mental illness.
- Failure to complete 6-month follow-up.
- Pregnancy or breastfeeding.
- Insertion torque of less than 35 N/cm.
- Removal of interim repair during the osseointegration stage.
- Patients suffering from parafunctional behaviors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr.mohamed khashaba, professor contact
Egypt1 site
Aya Tallah Selim Labib Kaream
Cairo, Shrouk, 4914085
aya tallah selim labib, master, 01143872045, aya.kaream@dentistry.cu.edu.eg
About this study
The research aims to evaluate the long-term effectiveness of satellite implants in the posterior mandible by assessing the levels of crestal bone after six months of first loading and secondary stability issues at fourth-month , primary stability at time of implant loading . In particular, the primary outcome of this study is to assessment stability of satellite implants, which will be evaluated by anycheck device.
Read the detailed description
satellite dental implants show potential for improving stability, and reducing crestal bone loss in the posterior mandible site, it offers effective solution for cases where primary stability is compromised due to poor bone quality or quantity. By providing additional support and anchorage, they enhance the overall stability of the implant, reducing the risk of failure and allowing for successful immediate loading. clinical evidence for their efficacy is still lacking. This prospective case series intends to fill this gap by evaluating crestal bone levels and stability factors in patients who are getting satellite implants for immediate loading in the posterior mandible. The results will improve clinical recommendations and practice for implant placements in the posterior mandible.
- Being tested
- satellite implant
- Keywords
- "Micro fixation ", "Immediate Loading", "Posterior Mandible", "Stability"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
satellite implantProcedure or surgery
Satellite implant is a additional holding component as a stabilizer to provide a polygonal support to distribute forces and moments on single-standing implants give the implant sufficient resistance to withstand masticatory forces or at least keep it in a stable position during an unloaded healing period to achieve stabilization and subsequent osseointegration of implants.
| Study group | Role | What they receive |
|---|---|---|
| Assessment stability of satellite implant | Experimental | Satellite implant is connecting microplate is attached to the implant's supra structure placed on the adjacent alveolus. Miniature "satellite" implant screws are inserted at approximal cortical sites to give the implant additional stability Receives: Procedure: satellite implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
After the insertion of the satellite implant, primary stability will be assessed at the time of implant loading using the "AnyCheck" device (Neo Biotech, Seoul, Korea). Introduced in 2017, the AnyCheck device evaluates implant stability through a damping capacity assessment method. It functions by striking the healing abutment six times over a span of three seconds. The contact duration between the impacting rod and the healing abutment is measured and converted into Implant Stability Test (IST) values. These values are quantified on a scale from 1 to 99, where higher IST values indicate greater implant stability or lower mobility. This quantitative measure provides a precise, reproducible method to assess the outcome of implant stability immediately after placement.
Measured: Immediately post-implantation
Secondary outcomes (1)
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
Assessment Tool: Secondary stability will be assessed using the "AnyCheck" device (Neo Biotech, Seoul, Korea). Introduced in 2017, this device specifically measures the damping capacity to evaluate implant stability.
Method: After the removal of the satellite implant four months post-procedure, the AnyCheck device will be employed to measure the secondary stability. The device operates by striking the healing abutment six times over a three-second period. The duration of contact between the impacting rod and the healing abutment is recorded.
Measurement Scale: The recorded contact time is then converted into Implant Stability Test (IST) values, which are displayed on a scale from 1 to 99. Higher IST values indicate greater implant stability, reflecting lower mobility of the implant within the bone.
Measured: The secondary stability is assessed four months post-implantation for each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start30 Dec 2025 (estimated)
- Primary completion22 Jun 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Novel Implant for Immediate Load in Posterior MandibleStudies 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Tallah Selim Labib Kaream, Cairo University
- Investigators
- Dr.hesham shalakamy, lecturer, Principal investigator, • Lecturer of Oral and Maxillofacial Surgery- Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486311
- Sponsor's protocol ID
- satellite implant
- Status last verified
- Feb 2025
- First submitted
- 22 Jun 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Engelke W, Stahr S, Schwarzwaller W. Enhancement of primary stability of dental implants using cortical satellite implants. Implant Dent. 2002;11(1):52-7. doi: 10.1097/00008505-200201000-00014.
PubMed 11915545Engelke W, Decco OA, de las Mercedes Capobianco M, Schwarzwaller W, Villavicencio MM. Immediate occlusal loading of freestanding implants using cortical satellite implants: preliminary report of a prospective study. Implant Dent. 2005 Mar;14(1):50-7. doi: 10.1097/01.id.0000154796.97355.2d.
PubMed 15764945
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
- ClinicalTrials.gov ID
- NCT06486311
- Acronym / sponsor ID
- satellite implant
- Keywords
- "Micro fixation ", "Immediate Loading", "Posterior Mandible", "Stability"
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 22 Jun 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 Jul 2024 (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 research aims to evaluate the long-term effectiveness of satellite implants in the posterior mandible by assessing the levels of crestal bone after six months of first loading and secondary stability issues at fourth-month , primary stability at time of implant loading . In particular, the primary outcome of this study is to assessment stability of satellite implants, which will be evaluated by anycheck device.
Detailed description
satellite dental implants show potential for improving stability, and reducing crestal bone loss in the posterior mandible site, it offers effective solution for cases where primary stability is compromised due to poor bone quality or quantity. By providing additional support and anchorage, they enhance the overall stability of the implant, reducing the risk of failure and allowing for successful immediate loading. clinical evidence for their efficacy is still lacking. This prospective case series intends to fill this gap by evaluating crestal bone levels and stability factors in patients who are getting satellite implants for immediate loading in the posterior mandible. The results will improve clinical recommendations and practice for implant placements in the posterior mandible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment stability of satellite implant | Experimental | Procedure: satellite implantSatellite implant is connecting microplate is attached to the implant's supra structure placed on the adjacent alveolus. Miniature "satellite" implant screws are inserted at approximal cortical sites to give the implant additional stability |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients requiring implants for the posterior mandible.
- Patients aged between 18-45 years old.
- Implants must be at least 8mm in length.
- A sufficient quantity and distribution of implants to enable cross-arch stability.
- Implants must have good initial stability, with insertion torques ranging from 35 to 50 N/cm.
Key exclusion criteria (15 listed)
- Contraindications to implant surgery in general.
- Bruxism.
- Immunosuppression.
- History of radiation to the head and neck region.
- Uncontrolled diabetes.
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 |
|---|---|---|
| satellite implantSatellite implant is a additional holding component as a stabilizer to provide a polygonal support to distribute forces and moments on single-standing implants give the implant sufficient resistance to withstand masticatory forces or at least keep it in a stable position during an unloaded healing period to achieve stabilization and subsequent osseointegration of implants. | Procedure or surgery | Assessment stability of satellite implant |
Primary outcome
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
Time frame: Immediately post-implantation
After the insertion of the satellite implant, primary stability will be assessed at the time of implant loading using the "AnyCheck" device (Neo Biotech, Seoul, Korea). Introduced in 2017, the AnyCheck device evaluates implant stability through a damping capacity assessment method. It functions by striking the healing abutment six times over a span of three seconds. The contact duration between the impacting rod and the healing abutment is measured and converted into Implant Stability Test (IST) values. These values are quantified on a scale from 1 to 99, where higher IST values indicate greater implant stability or lower mobility. This quantitative measure provides a precise, reproducible method to assess the outcome of implant stability immediately after placement.
1 secondary outcome
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
Time frame: The secondary stability is assessed four months post-implantation for each patient.
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 11 Feb 2025.
- Background: PubMed 11915545Engelke W, Stahr S, Schwarzwaller W. Enhancement of primary stability of dental implants using cortical satellite implants. Implant Dent. 2002;11(1):52-7. doi: 10.1097/00008505-200201000-00014.
- Background: PubMed 15764945Engelke W, Decco OA, de las Mercedes Capobianco M, Schwarzwaller W, Villavicencio MM. Immediate occlusal loading of freestanding implants using cortical satellite implants: preliminary report of a prospective study. Implant Dent. 2005 Mar;14(1):50-7. doi: 10.1097/01.id.0000154796.97355.2d.
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.
Dr.mohamed khashaba, professor contact
Dr.hesham shalakamy, lecturer principal investigator
• Lecturer of 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 satellite implant in people with Novel Implant for Immediate Load in Posterior Mandible, 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 8 inclusion and 15 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: opening soon, as of the sponsor's last update on 11 Feb 2025. 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?
Contact aya tallah selim labib, master (01143872045, aya.kaream@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible (time frame: Immediately post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06486311, which also lists 2 linked publications.
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 11 Feb 2025.