Clinical trial NCT06486311: Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
Official title: Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Novel Implant for Immediate Load in Posterior Mandible
Keywords: "Micro fixation "
"Immediate Loading"
"Posterior Mandible"
"Stability"
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 . 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
timeFrame: Immediately post-implantation
Secondary outcomes:
measure: Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
timeFrame: The secondary stability is assessed four months post-implantation for each patient.
Other outcomes:
measure: Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
timeFrame: 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.
Locations:
city: Cairo
country: Egypt
facility: Aya Tallah Selim Labib Kaream
state: Shrouk
Study officials:
affiliation: • Lecturer of Oral and Maxillofacial Surgery- Cairo University
name: Dr.hesham shalakamy, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Engelke 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.