Aya Tallah Selim Labib Kaream
Cairo, Shrouk, 4914085, Egypt
Not Yet Recruiting
NCT Number: NCT06486311
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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).
- 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.
Treatment and study plan
satellite implant
ProcedureSatellite 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.
Primary outcomes
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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.
Secondary outcomes
-
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.
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.
Other outcomes
-
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
Time frame: Crestal bone loss will be assessed at baseline (immediately post-implantation) and six months after the implant procedure. This timeframe allows for the monitoring of early bone remodeling and loss around the satellite implant.
Measurement Tool: CBCT combined with calibrated dental software.
Method: Crestal bone level will be precisely measured by assessing the interproximal height of bone. This is defined as the distance between the apical end of the first thread of the implant and the most coronal point of the interproximal crestal bone, both buccally and lingually. Measurements will be taken using digital periapical radiographs, which provide high-resolution images allowing for accurate assessment of bone levels.
Data Analysis: The height of the crestal bone will be recorded in millimeters. For each implant, the mean of the buccal and lingual bone heights will be calculated to determine the average crestal bone loss.
Measurement Scale: Measurements will be recorded in millimeters to provide a precise quantitative assessment of bone loss.
Study contacts
Contact information is provided by the study sponsor or research team.
Dr.mohamed khashaba, professor
CONTACT
aya tallah selim labib, master
CONTACT
Sponsors and collaborators
Lead sponsor
Cairo University
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Jul 3, 2024
- Registry last updated
- Feb 11, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.