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Not yet recruiting NCT06486311

Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible

No phase Interventional Novel Implant for Immediate Load in Posterior Mandible

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: satellite implant.
Who it may be relevant to
Registry conditions: Novel Implant for Immediate Load in Posterior Mandible. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure satellite implant
    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.

Primary outcome measures

  • Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible [Time frame: Immediately post-implantation]
Secondary outcome measures (1)
  • 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Aya Tallah Selim Labib Kaream — Cairo

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. PMID 11915545
  • 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. PMID 15764945

Identifiers

NCT: NCT06486311 · satellite implant

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗